Meet the 2017 Fellows!

By RAPS Membership Team posted 08-Mar-2018 16:11

  
RAPS Fellows are proven leaders in regulatory, committed to building and sharing regulatory knowledge that shapes the future of the profession. A rigorous selection process guarantees that only regulatory professionals with the highest qualifications and experience are elected each year to carry the "FRAPS" designation. Strong Fellows candidates mentor, write articles, volunteer their time, speak at conferences and go above and beyond their job description every day, just to nurture the profession. Do you have what it takes? 

Meet the 2017 Class of RAPS Fellows below. If you'd like to join their ranks keep scrolling for the opportunity to apply! 

292b11d9-0573-4710-ad05-d9493fe16152.jpgKaia Agarwal M.Sc., FRAPS

President
Regulatory Compass, LLC.

What do you love about the regulatory profession?
I love that over my entire career I was learning something new all the time – either the science or the regulations evolved.

What would we find on your desk right now?
A laptop, project files to work on for the day, a charger base for my phone and drawings that my mom did.

What are you reading right now?
Sapiens – a brief history of mankind – By Y. Harari

What does being a Fellow mean to you?
It is peer recognition of the many years and projects I have worked on during my time in this profession.

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3df93cae-6ffb-4261-a28b-47f7b44f120f.jpgSusan K. Hamann MS, MT(ASCP), RAC, FRAPS
President
Hamann QR Consulting, LLC

What does being a Fellow mean to you?
It's a great honor to have been named a RAPS Fellow. I love working with other people in the regulatory profession and the staff at RAPS is so supportive. RAPS is the logical organization to help each of us become the most accomplished and knowledgeable regulatory professionals that we can be.  I've enjoyed being able to bring some of those services to the local regulatory population in the Boston area. 

Which do you prefer? Coffee? Or tea?
Never coffee and always tea, either hot or cold. I love blends, flavored teas and different types of tea– hot and iced.

What are you reading right now?
Two books, both by popular women authors. On paper, I'm reading Sunburn by Laura Lippman. On audio, I'm reading The Great Alone by Kristin Hannah. Also numerous magazines and daily Boston Globe. And of course, regulatory updates from multiple sources.

What are you most looking forward to this year?
I'm working with a few clients to get them prepared for MDSAP. It's the next big hurdle for many of us in the medical device arena, followed by the new European regulations. On a personal level, I'm looking forward to a move from the Boston area to Delaware to be closer to family. I hope to continue my work from there. I will be handing off the leadership of the RAPS Boston chapter to a new leader, David Leo and the rest of the local chapter leaders.

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77959390-f14e-4ef3-9614-20333723efcf.jpgJoel Kent MSc., RAC, FRAPS
Senior Manager, Regulatory Affairs
GE Healthcare

What does being a Fellow mean to you?
It means recognition for teaching, mentoring others and carrying that leadership forward throughout my whole career. 

What would we find on your desk right now?
I can’t really find my desk right now actually! 

What are you reading right now?
Cloud Computing (The RA world is changing so we need to keep up!) 

What are you most looking forward to this year?
Regulatory wise: FDA providing guidance on the regulation of software and Digital Health products. Personally: Being on a boat this summer! 

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8c99f257-2b2a-43b3-bd10-1950ada23df3.jpgDarin Oppenheimer DRSc, RAC, FRAPS
Executive Director
Drug-Device Center of Excellence

Merck 

What do you love about the regulatory profession?
I love the opportunities and challenges we face daily as a regulatory professional. I specifically enjoy focusing on policy, regulatory intelligence and strategically guiding product development teams to market and maintain products to benefit patients and healthcare professionals .

Which do you prefer? Coffee? Or tea?
Neither– I am a big fan of Diet Coke or Diet Pepsi.

What are you reading right now?
I am currently reading two books, True North and the Harvard Business Review.

What would we find on your desk right now?
A large printed copy of the EU Medical Device Regulations with plenty of notes embedded on each page.

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3082972c-223f-43d8-ae85-e33cc900f3c9.jpgJoanne Palmisano MD., FACP, FRAPS
Vice President, Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc. 

What do you love about the regulatory profession?
The Regulatory Affairs (RA) professional is an integral partner in the drug development program in all phases of development, and in the path towards approval and bringing a medicine to patients. Depending on the functional area of RA, that professional may be responsible for the global strategy for a development program on a core matrix product team, the CMC expert for a development program, responsible for guiding labeling, ensuring compliance with promotion and advertising or an expert in regulatory operations/submissions, product maintenance, devices or regulatory policy working on key issues that are critical to advancing the science of drug development. We have connections with the multiple subject matter experts in medicine, pharmacovigilance, statistics, R&D, pharmacology, etc. which enriches our understanding of the complexity of drug development challenges. The opportunity to be the facilitator of important interactions with global health authorities is a privilege and part of the excitement that comes with this position.

What would we find on your desk right now?
I feel fortunate to lead an organization in a company that has multiple assets in multiple therapeutic areas, many of these assets with the opportunity for innovative drug development and regulatory strategies. I am reviewing and providing guidance on several meeting requests/briefing documents for FDA interactions on these development programs. In addition, I am a member of the Expert Working Group for ICH E8(R1): General Considerations for Clinical Studies. The goal of ICH E8(R1) is to provide guidance to address the increasing diversity of clinical study designs and data sources used to support regulatory and other health policy decisions. I am currently working with my sections authoring group to provide a draft of the clinical development for this harmonized guidance.

What are you reading right now?
I love to read, and I choose books that allow me to escape into another world or time. I am just beginning book three of Elena Ferrante’s Neapolitan novels. I wish I could read these in the original Italian, but the English translations are amazing, and this story of love and friendship is wonderful.

What does being a Fellow mean to you?
It is an honor and privilege to be selected as a RAPS Fellow. This recognition solidifies my commitment to continue to develop strong regulatory affairs professionals in my organization. I was challenged by strong leaders in regulatory affairs in my career, and I see this as an important part of our leadership commitment to our departments and to our companies. 

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Apply now to be considered for the 2018 class of RAPS Fellows!

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