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Regulatory Management and Leadership Ask Me Anything session

  • 1.  Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 12:58
    Hi Members,

    Recently, RAPS released it's quarterly article series focusing on current trends and best practices in Regulatory Management and Leadership Strategies. Today, we have six experts: @Jethro Ekuta, @Steven Jwanouskos, @Olivia McBride, @Ryan McNeely, @Allison Komiyama, and @William Sietsema, who are here to discuss the most recent Regulatory Focus article series, and answer your questions in real-time.

    Please use this thread to ask the experts your questions.

    Can't wait to read the discussions!

    Best,
    Emily​​​​​​

    ------------------------------
    Emily Stamm
    Community Manager
    Regulatory Affairs Professionals Society®
    regex@raps.org
    ------------------------------


  • 2.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:00
    Hi, this is Bill Sietsema. Looking forward to everyone's questions and contributing to the answers.

    ------------------------------
    William Sietsema
    Rancho Santa Margarita CA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:37
    Bill, another question for you...in your article, you mentioned that finding a mentor is a good way to break into the regulatory field for a young professional. I couldn't agree more as mentors were a big help to me when starting out!  How do you suggest people find good mentors?  Also, what makes a good mentor?

    ------------------------------
    Allison Komiyama
    AcKnowledge RS
    San Diego CA United States
    www.acknowledge-rs.com
    ------------------------------

    Original Message


  • 4.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:41
    I suppose in many cases, mentor and mentee sort of stumble across each other and hit it off, but one can also look for a mentor on LinkedIn or can ask someone they know in the field who might be a good mentor. I think in many cases, mentors are suggested from someone else that the mentee holds in high esteem. I think a good mentor is someone who is well connected and knows how to find answers, plus has the time to help on short notice when needed. I couldn't agree more that having a good mentor can be a strong predictor of career progression.

    ------------------------------
    William Sietsema
    Rancho Santa Margarita CA
    United States
    ------------------------------

    Original Message


  • 5.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:41
    Allison - Mentors are also great when you return to work. I had a mentor when I started work again and it was essential in helping me get back on top.

    ------------------------------
    Olivia McBride
    Consultant
    Uxbridge
    United Kingdom
    ------------------------------

    Original Message


  • 6.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:00
    Thanks @Emily Stamm !  Happy to be here and looking forward to any/all questions!

    ------------------------------
    Allison Komiyama
    AcKnowledge RS
    San Diego CA United States
    www.acknowledge-rs.com/regulatoryaf
    ------------------------------

    Original Message


  • 7.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:01
    My name is Jethro Ekuta. I'm currently a member of the RAPS Board of Directors. Looking forward to a great discussion today!

    ------------------------------
    Jethro Ekuta DVM, FRAPS, RAC, PhD
    Audubon PA
    United States
    ------------------------------

    Original Message


  • 8.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:31
    Hi Jethro - what are you looking forward to at convergence this year? Hot topics?

    ------------------------------
    William Sietsema
    Rancho Santa Margarita CA
    United States
    ------------------------------

    Original Message


  • 9.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:38
    Every Convergence for me is a great opportunity for networking, giving me an opportunity to meet with new professional colleagues, health authority staffers, new technology presented by exhibitors, and even former colleagues that I have not seen in a long time. In addition, I learn new things about our constantly evolving profession, and give back to the Community through my participation in group sessions. I look forward to doing the same thing at this year's conference, which is taking place in my very own hometown of the City of Brotherly Love - can't wait to expose attendees to the exciting things that our beloved city has to offer!

    ------------------------------
    Jethro Ekuta DVM, FRAPS, RAC, PhD
    Audubon PA
    United States
    ------------------------------

    Original Message


  • 10.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:01
    Hi Everyone. This is Olivia McBride. I\m looking forward to answering any questions you may have on returning to work after a long career break. ​

    ------------------------------
    Olivia McBride
    Consultant
    Uxbridge
    United Kingdom
    ------------------------------

    Original Message


  • 11.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:12
    Olivia, your pathway was inspiring and I really appreciate you sharing your story on the Regulatory Focus series.  I know so many people who are interested in getting back in to regulatory affairs but are nervous to do so after any type of hiatus.  I'm wondering, what were the main challenges you faced returning to work after a 10 year career break?

    ------------------------------
    Allison Komiyama
    AcKnowledge RS
    San Diego CA United States
    www.acknowledge-rs.com
    ------------------------------

    Original Message


  • 12.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:17
    Hi Allison. That's a great question. The two main challenges I faced were: Getting back up to speed as the industry had moved on so much in 10 years with new regulations and ways of working coming into play not to mention how much technology had moved on. There was a lot to learn.
    And confidence. Having been out of work for so long just looking after my family I felt unsure about my abilities in a professional capacity.

    ------------------------------
    Olivia McBride
    Consultant
    Uxbridge
    United Kingdom
    ------------------------------

    Original Message


  • 13.  RE: Regulatory Management and Leadership Ask Me Anything session

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2019 13:28
    This message was posted by a user wishing to remain anonymous

    Hi Olivia!

    I am curious how you overcame these challenges? How did you get yourself back up to speed?
    Original Message


  • 14.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:30
    To get back up to speed, I spent weeks on the internet reading everything I could find on the world of regulatory affairs. I signed up to regulatory newsletters, looked on agency websites and read regulatory publications to familarise myself with all the latest buzzwords, new regulations and their impact and trends in the industry. I also reached out and met with my old colleagues which really helped with my confidence remembering all the projects I'd worked on and the things I'd achieved as a regulatory professional.

    ------------------------------
    Olivia McBride
    Consultant
    Uxbridge
    United Kingdom
    ------------------------------

    Original Message


  • 15.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:20
    Hi Allison - I was wondering if you had any thoughts on the FDA website redesign? I have found a few things challenging.

    ------------------------------
    William Sietsema
    Rancho Santa Margarita CA
    United States
    ------------------------------

    Original Message


  • 16.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:24
    I agree!  Definitely some of the fonts are harder to read though maybe I just need to get new reading glasses?  While I know FDA continues to try and improve the website and database functionality, there have been many links that I can no longer find since the redesign.  I'm curious as to your thoughts as well!

    ------------------------------
    Allison Komiyama
    AcKnowledge RS
    San Diego CA United States
    www.acknowledge-rs.com
    ------------------------------

    Original Message


  • 17.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:28
    I wasn't bothered as much by the fonts as in trying to find things. I had to learn all over again where things are kept. But there are some additional issues. One is that it seems difficult now to identify a link that can be used to reference an item. Links don't work the way they used to. Also, some of the older items have been moved to an archive site where they are organized differently and not always searchable. And whereas there used to be a calendar for scheduled advisory committee meetings, now they don't show meetings until they have been confirmed and scheduled and they only look outwards about 6 weeks at the most.

    ------------------------------
    William Sietsema
    Rancho Santa Margarita CA
    United States
    ------------------------------

    Original Message


  • 18.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:01
    ​Hi Emily,

    Thank you for inviting me to participate.

    I am a Regulatory Operations professional with extensive submission experience managing all types of eCTD submissions to health authorities.  My article "eCTD Submission Management" was recently featured in the Regulatory Focus series and I am happy to answer any questions the community may have.

    https://www.raps.org/news-and-articles/news-articles/2019/8/ectd-submission-management

    Thanks!
    Ryan

    ------------------------------
    Ryan McNeely
    Regulatory Operations Manager
    Berwyn PA
    United States
    ------------------------------

    Original Message


  • 19.  RE: Regulatory Management and Leadership Ask Me Anything session

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2019 13:21
    This message was posted by a user wishing to remain anonymous

    Hi @Ryan McNeely,

    I was wondering, what benefits have you seen in promoting cross training between functional groups?​
    Original Message


  • 20.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:24
    Edited by Ryan McNeely 10-Sep-2019 13:25
    ​From a regulatory operations standpoint I've found it critical to have the upstream authoring groups understand our publishing and review processes.  Last minute changes to content during submission finalization can put a strain on resources and if the authors understand the impact to our process they are less likely to make non-essential changes to content. Similar benefits can be found in working collaboratively from the very start of the project - the earlier in the process each group understands each other the greater the impact that can be realized.

    ------------------------------
    Ryan McNeely
    Regulatory Operations Manager
    Berwyn PA
    United States
    ------------------------------

    Original Message


  • 21.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 13:53
    In addition, cross training between functional groups can greatly reduce misunderstanding and foster greater collaboration. When colleagues know about the work that others do and and how they do it, it often gives them a better appreciation of the value that these colleagues bring to the table and how they can leverage one another's expertise in solving common problems. It can certainly help to break down silos.

    ------------------------------
    Jethro Ekuta DVM, FRAPS, RAC, PhD
    Audubon PA
    United States
    ------------------------------

    Original Message


  • 22.  RE: Regulatory Management and Leadership Ask Me Anything session

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2019 13:49
    This message was posted by a user wishing to remain anonymous

    @Steven Jwanouskos  ​What made you decide to make the switch to advertising and promotion regulatory review? What considerations would you suggest to someone thinking about making a similar switch?
    Original Message


  • 23.  RE: Regulatory Management and Leadership Ask Me Anything session

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2019 13:58
    This message was posted by a user wishing to remain anonymous

    Hi Experts,

    What changes or challenges in the regulatory landscape do you see on the horizon? What can we do to prepare for these challenges?
    Original Message


  • 24.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 14:00
    I think one of the biggest ongoing issues is need to harmonize global requirements. Despite efforts by ICH, there continue to be many regional differences in expectations that lead to inefficiencies in drug development.

    ------------------------------
    William Sietsema
    Rancho Santa Margarita CA
    United States
    ------------------------------

    Original Message


  • 25.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 12-Sep-2019 17:51
    For colleagues in the pharmaceuticals / biotech world, precision medicine is gaining momentum in leaps and bounds and we can anticipate that the FDA and other health authorities will develop new guidance documents as time goes on. Also, it is becoming increasingly clear that the regulatory pathways for the development of products for rare diseases are truly unique and health authorities are exploring ways to evolve an efficient regulatory landscape for this group of diseases that takes into consideration this uniqueness. Both of these developments - precision medicine and rare diseases - provide many opportunities for regulatory professionals to lead collaborations with health authorities and help shape the regulatory environment.

    ------------------------------
    Jethro Ekuta DVM, FRAPS, RAC, PhD
    Audubon PA
    United States
    ------------------------------

    Original Message


  • 26.  RE: Regulatory Management and Leadership Ask Me Anything session

    Posted 10-Sep-2019 14:00
    Thanks for joining us for this wonderful session, and a big thank you to our experts Jethro, Steve, Olivia, Ryan, Allison, and Bill.

    As a reminder, you can find the Regulatory Focus Article Series, Regulatory Management and Leadership HERE.

    Feel free to keep the conversation going by adding your question to this thread.

    Thanks again!

    ------------------------------
    Emily Stamm
    Community Manager
    Regulatory Affairs Professionals Society®
    regex@raps.org
    ------------------------------

    Original Message


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