Regulatory Open Forum

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Dear Lena,

sounds like a good plan! And respect for making it public. Perhaps our paths cross at the meeting.

My biggest challenge? Somehow same as yours... :-)

Best,

Dirk

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi Lena,

As someone who spent the first half of my regulatory career in the IDE and PMA world and began to work with Class I and II much later, I can say that I've learned a great deal in recent years from professionals such as yourself (How do I find the best predicate? Is this Class I or II?).  While each area has its own unique challenges, there are many more that are common across the board (managing information overload, handling advertising and promotion, AE reporting, compliance issues, etc.). 

In my opinion, one of the greatest advantages of RAPS is what we can all learn from our colleagues by sharing our struggles and experience.  I applaud you for your commitment to stepping out of your comfort zone, and look forward to hearing from you at the Convergence!

Sharon

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Lena, one of my favorite quotes is Mark Twain's "All men are ignorant, just on different subjects."  

All questions will be elemental to some folks; the same questions will be a challenge to others.  Moreover, if you think about it...if you really want a good answer, it is precisely the person for whom the question is elemental that you want to ask, as they are the ones who should know.

It's true that Class III is a rarified and complex regulatory environment.  But the regulatory expertise you develop with a PMA is deep and narrow, often with limited application to any other device that ever was or...because a PMA device can't be used as a predicate...to any other device that ever will be.  People who work with Class I's and II's typically have a much broader knowledge of the regulations than us Class III types, and their knowledge is more readily applied to a wide range of devices, I think.

So, ask away, and have a great Convergence!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi Lena

One of the other ways you can network is during lunch and breaks at the Annual Conference.  Sit down at a table with people you don't know and ask them if they have been to any great sessions and why.  I have found people want to talk about the sessions they went to that they thought were great and you may even learn something from them.  I also will go an talk to people that have asked questions in a session to see what they thought of the answer or to provide some insight that I might have.  I have found our profession to be extremely nice people that enjoy meeting others that do what they do.

The dine-arounds are another way to meet people that you never knew before and find out where they are from and what sessions they have enjoyed. 

I am leading a couple of sessions in the legal track.  If you come to them, stop by and introduce yourself!

See you in San Jose!

Meg

Lena, one of my favorite quotes is Mark Twain's "All men are ignorant, just on different subjects."  

All questions will be elemental to some folks; the same questions will be a challenge to others.  Moreover, if you think about it...if you really want a good answer, it is precisely the person for whom the question is elemental that you want to ask, as they are the ones who should know.

It's true that Class III is a rarified and complex regulatory environment.  But the regulatory expertise you develop with a PMA is deep and narrow, often with limited application to any other device that ever was or...because a PMA device can't be used as a predicate...to any other device that ever will be.  People who work with Class I's and II's typically have a much broader knowledge of the regulations than us Class III types, and their knowledge is more readily applied to a wide range of devices, I think.

So, ask away, and have a great Convergence!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi Lena,

I was planning on starting a similar thread so thanks for doing that. I have just been made the regulatory affairs manager at my company and enrolled for the pre-workshops for the RAPS Convergence. I am quite overwhelmed at the moment as well. I am travelling all the way from Australia to attend this event and trying to prepare myself so I can make the most out of it. As I said, I have just come in to the role and with not much of any prior RA background I am really hesitant about networking and feel that I will be looked at as being very novice in the field (which I am). I am trying to read and research about the regulatory framework  for FDA for different devices and find myself very lost. So my personal challenge is networking as well as ensuring that I get some positive output from these workshops.

Hi Lena,

I was planning on starting a similar thread so thanks for doing that. I have just been made the regulatory affairs manager at my company and enrolled for the pre-workshops for the RAPS Convergence. I am quite overwhelmed at the moment as well. I am travelling all the way from Australia to attend this event and trying to prepare myself so I can make the most out of it. As I said, I have just come in to the role and with not much of any prior RA background I am really hesitant about networking and feel that I will be looked at as being very novice in the field (which I am). I am trying to read and research about the regulatory framework  for FDA for different devices and find myself very lost. So my personal challenge is networking as well as ensuring that I get some positive output from these workshops.

Hi Lena

One of the other ways you can network is during lunch and breaks at the Annual Conference.  Sit down at a table with people you don't know and ask them if they have been to any great sessions and why.  I have found people want to talk about the sessions they went to that they thought were great and you may even learn something from them.  I also will go an talk to people that have asked questions in a session to see what they thought of the answer or to provide some insight that I might have.  I have found our profession to be extremely nice people that enjoy meeting others that do what they do.

The dine-arounds are another way to meet people that you never knew before and find out where they are from and what sessions they have enjoyed. 

I am leading a couple of sessions in the legal track.  If you come to them, stop by and introduce yourself!

See you in San Jose!

Meg

Lena, one of my favorite quotes is Mark Twain's "All men are ignorant, just on different subjects."  

All questions will be elemental to some folks; the same questions will be a challenge to others.  Moreover, if you think about it...if you really want a good answer, it is precisely the person for whom the question is elemental that you want to ask, as they are the ones who should know.

It's true that Class III is a rarified and complex regulatory environment.  But the regulatory expertise you develop with a PMA is deep and narrow, often with limited application to any other device that ever was or...because a PMA device can't be used as a predicate...to any other device that ever will be.  People who work with Class I's and II's typically have a much broader knowledge of the regulations than us Class III types, and their knowledge is more readily applied to a wide range of devices, I think.

So, ask away, and have a great Convergence!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Harsha,

Of course you are a bit overwhelmed now - we all were when we first got into Regulatory as it seems like there are a million things to know. But in the end, you will learn it and hopefully enjoy it. Convergence is a great place to start - there are usually fantastic sessions on the "basics" that cater to newer RA professionals. I am so glad you were able to get approval to come to it all the way from Australia! A few things you can do to optimize the experience:

1) plan out your sessions ahead of time - try for a cross section of topics you think might apply to your companies products but pick at least one that "just interests you"

2) as someone else said earlier - always have backups for time slots, just in case a room is over full or the topic does not quite turn out to be what you wanted

3) at lunch/networking etc, feel free to tell folks you are new and ask if they will help you with a question you are struggling with. You will be surprised how many people will willingly help. Most of us know that at some point we will be the one with questions - plus, it is often fun to think about a problem that is not on your specific companies products!

Also, as you get started, don't be afraid to reach out to regulators. In your home market, the I have always found the TGA to be not only highly skilled, but very helpful in working with people to comply with their regulations. Health Canada is much the same. And for the US FDA, their "small business' group (DICE) is often very helpful pointing you to information to deal with a specific question.

You can do this.

g-

Hi Lena,

I was planning on starting a similar thread so thanks for doing that. I have just been made the regulatory affairs manager at my company and enrolled for the pre-workshops for the RAPS Convergence. I am quite overwhelmed at the moment as well. I am travelling all the way from Australia to attend this event and trying to prepare myself so I can make the most out of it. As I said, I have just come in to the role and with not much of any prior RA background I am really hesitant about networking and feel that I will be looked at as being very novice in the field (which I am). I am trying to read and research about the regulatory framework  for FDA for different devices and find myself very lost. So my personal challenge is networking as well as ensuring that I get some positive output from these workshops.

Hi Lena

One of the other ways you can network is during lunch and breaks at the Annual Conference.  Sit down at a table with people you don't know and ask them if they have been to any great sessions and why.  I have found people want to talk about the sessions they went to that they thought were great and you may even learn something from them.  I also will go an talk to people that have asked questions in a session to see what they thought of the answer or to provide some insight that I might have.  I have found our profession to be extremely nice people that enjoy meeting others that do what they do.

The dine-arounds are another way to meet people that you never knew before and find out where they are from and what sessions they have enjoyed. 

I am leading a couple of sessions in the legal track.  If you come to them, stop by and introduce yourself!

See you in San Jose!

Meg

Lena, one of my favorite quotes is Mark Twain's "All men are ignorant, just on different subjects."  

All questions will be elemental to some folks; the same questions will be a challenge to others.  Moreover, if you think about it...if you really want a good answer, it is precisely the person for whom the question is elemental that you want to ask, as they are the ones who should know.

It's true that Class III is a rarified and complex regulatory environment.  But the regulatory expertise you develop with a PMA is deep and narrow, often with limited application to any other device that ever was or...because a PMA device can't be used as a predicate...to any other device that ever will be.  People who work with Class I's and II's typically have a much broader knowledge of the regulations than us Class III types, and their knowledge is more readily applied to a wide range of devices, I think.

So, ask away, and have a great Convergence!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Lena, one of my favorite quotes is Mark Twain's "All men are ignorant, just on different subjects."  

All questions will be elemental to some folks; the same questions will be a challenge to others.  Moreover, if you think about it...if you really want a good answer, it is precisely the person for whom the question is elemental that you want to ask, as they are the ones who should know.

It's true that Class III is a rarified and complex regulatory environment.  But the regulatory expertise you develop with a PMA is deep and narrow, often with limited application to any other device that ever was or...because a PMA device can't be used as a predicate...to any other device that ever will be.  People who work with Class I's and II's typically have a much broader knowledge of the regulations than us Class III types, and their knowledge is more readily applied to a wide range of devices, I think.

So, ask away, and have a great Convergence!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi everyone,

My personal challenge is to network with professionals across the business and not be afraid to ask questions (so similar to you, Lena). I am fairly new to the regulatory field, so I will be actively pushing myself to attend sessions that can not only benefit the company but 1 or 2 that simply interest me.

Another challenge I've set for myself is to learn more about the medical device companies on the West Coast, as it is a place I can see myself moving to a few years down the road. I am quite familiar with businesses on the East Coast but apart from major corporations, I am not too knowledgeable of the med device landscape in CA.

Thank you Lena for starting this thread and all the great advice about networking specifics from everyone else. I especially liked the tip about having a backup session. I'll definitely go and mark my backups before Convergence! I look forward to meeting you all.

Hiral

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hiral,

Thank you for sharing your Convergence Challenge! I would love to meet up with you in person at Convergence if you are available. RAPS will have the RAPS Event app again this year, so I will make a note to myself to contact you when I arrive.

Hi everyone,

My personal challenge is to network with professionals across the business and not be afraid to ask questions (so similar to you, Lena). I am fairly new to the regulatory field, so I will be actively pushing myself to attend sessions that can not only benefit the company but 1 or 2 that simply interest me.

Another challenge I've set for myself is to learn more about the medical device companies on the West Coast, as it is a place I can see myself moving to a few years down the road. I am quite familiar with businesses on the East Coast but apart from major corporations, I am not too knowledgeable of the med device landscape in CA.

Thank you Lena for starting this thread and all the great advice about networking specifics from everyone else. I especially liked the tip about having a backup session. I'll definitely go and mark my backups before Convergence! I look forward to meeting you all.

Hiral

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi everyone!

Thank you Lena for opening this discussion! This will be my 18th RAPS conference and was just thinking what should be my goals for RAPS 2016... I love that topic a lot!

I will be chairing the pre-conference workshop on Regulatory Strategy for Medical Device Forum for the third year in a row and of course I look forward to energize the room along with my 3 fellow presenters. We ask a lot from our students and in return we hope to make sure they go home with lots of good learning's!

As Meg mentioned before, there are so many ways to network at RAPS. Have you ever participated in a dine-around? That is where I met many of my mentors and where I strongly recommend folks to try. The best networking outcomes for me took place when I purposely got out of my comfort zone and reached out to get to know their peers (like playing ice breaking games at dinner,,, I am sure some people on this tread remember some memorable moments at multiple dine-arounds). There are many ways to break the ice and in return this allows for very great RA conversations to take place - discussing our struggles (without divulging confidential company information) is certainly a great way to learn how to be the best RA Professionals that we can.

I bet and certainly hope we see each other in San Jose!!!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hello RAPS Community,

This is my first post on the exchange and the first time going to the RAPS Convergence.

I am new to the regulatory world and am so excited, but nervous about the convergence because I will be there by myself. I recently started my masters in regulatory so I cant wait to meet people from all over the world and learn from your experience. If you are from the Minneapolis, MN area maybe we could meet up for coffee? 

Looking forward to a fun and educational time!

Hi everyone!

Thank you Lena for opening this discussion! This will be my 18th RAPS conference and was just thinking what should be my goals for RAPS 2016... I love that topic a lot!

I will be chairing the pre-conference workshop on Regulatory Strategy for Medical Device Forum for the third year in a row and of course I look forward to energize the room along with my 3 fellow presenters. We ask a lot from our students and in return we hope to make sure they go home with lots of good learning's!

As Meg mentioned before, there are so many ways to network at RAPS. Have you ever participated in a dine-around? That is where I met many of my mentors and where I strongly recommend folks to try. The best networking outcomes for me took place when I purposely got out of my comfort zone and reached out to get to know their peers (like playing ice breaking games at dinner,,, I am sure some people on this tread remember some memorable moments at multiple dine-arounds). There are many ways to break the ice and in return this allows for very great RA conversations to take place - discussing our struggles (without divulging confidential company information) is certainly a great way to learn how to be the best RA Professionals that we can.

I bet and certainly hope we see each other in San Jose!!!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi everyone!

Thank you Lena for opening this discussion! This will be my 18th RAPS conference and was just thinking what should be my goals for RAPS 2016... I love that topic a lot!

I will be chairing the pre-conference workshop on Regulatory Strategy for Medical Device Forum for the third year in a row and of course I look forward to energize the room along with my 3 fellow presenters. We ask a lot from our students and in return we hope to make sure they go home with lots of good learning's!

As Meg mentioned before, there are so many ways to network at RAPS. Have you ever participated in a dine-around? That is where I met many of my mentors and where I strongly recommend folks to try. The best networking outcomes for me took place when I purposely got out of my comfort zone and reached out to get to know their peers (like playing ice breaking games at dinner,,, I am sure some people on this tread remember some memorable moments at multiple dine-arounds). There are many ways to break the ice and in return this allows for very great RA conversations to take place - discussing our struggles (without divulging confidential company information) is certainly a great way to learn how to be the best RA Professionals that we can.

I bet and certainly hope we see each other in San Jose!!!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi everyone!

Thank you Lena for opening this discussion! This will be my 18th RAPS conference and was just thinking what should be my goals for RAPS 2016... I love that topic a lot!

I will be chairing the pre-conference workshop on Regulatory Strategy for Medical Device Forum for the third year in a row and of course I look forward to energize the room along with my 3 fellow presenters. We ask a lot from our students and in return we hope to make sure they go home with lots of good learning's!

As Meg mentioned before, there are so many ways to network at RAPS. Have you ever participated in a dine-around? That is where I met many of my mentors and where I strongly recommend folks to try. The best networking outcomes for me took place when I purposely got out of my comfort zone and reached out to get to know their peers (like playing ice breaking games at dinner,,, I am sure some people on this tread remember some memorable moments at multiple dine-arounds). There are many ways to break the ice and in return this allows for very great RA conversations to take place - discussing our struggles (without divulging confidential company information) is certainly a great way to learn how to be the best RA Professionals that we can.

I bet and certainly hope we see each other in San Jose!!!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hello Nicole,

Nice to know that you will be chairing the Regulatory Strategy Workshop at the Convergence again this year. I attended the workshop last year in Baltimore and found it to be very thought-provoking and an in-depth workshop. The template used is very helpful as well. If you have made revisions to it after the workshop last year, is there a way for the "alumni's" to get a copy of the latest version? For Lena, Harsha and Hiral, attending a workshop is another way to network if you have an opportunity to do that.

Kanu Vadodaria

Hi everyone!

Thank you Lena for opening this discussion! This will be my 18th RAPS conference and was just thinking what should be my goals for RAPS 2016... I love that topic a lot!

I will be chairing the pre-conference workshop on Regulatory Strategy for Medical Device Forum for the third year in a row and of course I look forward to energize the room along with my 3 fellow presenters. We ask a lot from our students and in return we hope to make sure they go home with lots of good learning's!

As Meg mentioned before, there are so many ways to network at RAPS. Have you ever participated in a dine-around? That is where I met many of my mentors and where I strongly recommend folks to try. The best networking outcomes for me took place when I purposely got out of my comfort zone and reached out to get to know their peers (like playing ice breaking games at dinner,,, I am sure some people on this tread remember some memorable moments at multiple dine-arounds). There are many ways to break the ice and in return this allows for very great RA conversations to take place - discussing our struggles (without divulging confidential company information) is certainly a great way to learn how to be the best RA Professionals that we can.

I bet and certainly hope we see each other in San Jose!!!

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

20 new people a day!

I love your challenge, but I recommend a more manageable number. Quantity is more important that quality. Twenty sounds like a scavenger hunt more than a meaningful meeting.

Instead of 20 a day, how about, at each break, connect with someone you already know but missed them over the past 2-12 months, and at alternate breaks, connect with 1 new person. That will give you time to find out about each person, have a meaningful conversation, and get their card for follow up, rather than be scanning the room for the next person to make your "20."

And be sure to attend the dine-around. Don't chose one with people with you know. Excuse yourself from the "usual suspects" to mingle.

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

Hi Andrea,

Thank you for commenting. My goals are to ask 1 question/day but meet 20 people in total! I like to talk but not sure I can talk that much lol. I will consider the dine-arounds as a possibility, but I really like to use the dinners to catch up with colleagues I have met at previous Convergence conferences. A bit backwards from what other attendees do, but it works!

20 new people a day!

I love your challenge, but I recommend a more manageable number. Quantity is more important that quality. Twenty sounds like a scavenger hunt more than a meaningful meeting.

Instead of 20 a day, how about, at each break, connect with someone you already know but missed them over the past 2-12 months, and at alternate breaks, connect with 1 new person. That will give you time to find out about each person, have a meaningful conversation, and get their card for follow up, rather than be scanning the room for the next person to make your "20."

And be sure to attend the dine-around. Don't chose one with people with you know. Excuse yourself from the "usual suspects" to mingle.

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

I was quite a bit behind on reading through these forum digest emails, so I'm going to "bump" this older topic.

Lena - I love that you made your goals public and that you are following up with others here about how to implement them.

This will be my 4th Convergence, but my first since leaving a "traditional" RA role for one in consulting.  I am really looking forward to discussing topics which are causing strife for my fellow regulatory colleagues.  I'm also looking forward to catching up with some old colleagues and continuing to build my network as well.

The Dine-Arounds have been a favorite of mine in the past, so I am VERY excited to be leading one this year!  I hope to meet many of you soon.  Please don't hesitate to introduce yourself to me and I will certainly do the same.

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable! 

As I prepare to attend my 11th? RAPS Convergence, I am acknowledging once again to myself that networking is one of my biggest weaknesses. (I know, people who know me have a difficult time believing that.) What do I have to offer to a conversation? How can someone with Class I & II device experience carry on an intelligent conversation with a Class III RA professional? My questions are going to sound too elemental. Too often I have sat in the back row, avoided making eye contact, skirted the microphones, and ran from the room as quickly as possible. 

So I have decided that to continue to grow professionally and to be a thought leader, I need to change. What better way to do that than give myself specific goals for this years Convergence, make it public so my fellow RAPPERS can hold me accountable, and challenge others to do the same! 

These aren't earth shattering goals but they will challenge me to actively "be in the moment" at every session and to always be ready to step out of my comfort zone. <<deep breath>> And here I go:

1. Ask one question a day.
2. Meet 20 new people (I better pack extra business cards!)
3. Attend a session topic that is completely new for me.

What is your personal challenge? I'd love to hear it and help hold you accountable!