RAPS Regulatory Affairs Professionals Society Conference 2014

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I recently attended the RAPS (Regulatory Affairs Professionals Society) conference in Austin, Texas. This was a fascinating eye-opener to the sector involved in the regulation of healthcare and related products, including pharmaceuticals, medical devices and nutritional supplements. As practicing physicians, we are familiar with all of these entities; we prescribe medications, have patients with pacemakers and artificial hips, and we might recommend vitamins or Omega-3 fish oil. However, we may not know much about the career opportunities in regulatory affairs or the individuals doing this important work.

At the RAPS conference, I had the chance to meet some of these folks. I don’t know if it’s because regulatory affairs tends to attract people who like to follow rules, care about quality, and have a high degree integrity, but this was a really great group of professionals. No one butted in line when the “Hey Cupcake” trailer opened during a break. Recruiters and attendees I spoke with were more than willing to share information and advice. And the conference as a whole was incredibly well-organized and thoughtfully presented. There were 5 different special interest tracts one could pick and choose from, conveniently color coded for easy reference. The tracts were:

  • Biologics and Biotechnology
  • Health-Related Foods
  • Pharmaceuticals
  • Medical Devices and In Vitro Diagnostics
  • Regulatory Business

One of the seminars I attended was on Pediatric Medical Devices. In this presentation, pediatrician Linda Ulrich, MD, FAAP, director in the Office of Orphan Products Development at the FDA, eloquently captured the connection of regulatory affairs to the chain of device development when she said, “A clinician needs an engineer, who needs a business person, who needs someone who thinks like a regulator.” She and the other speakers stressed the need for the development of devices specific for children, instead of having to resort to jury-rigged devices designed for adults.

There were some great career workshops where RAPS fellows (members who are seasoned veterans in regulatory affairs) shared their career stories and offered sage advice to aspiring attendees. Some pearls from these sessions were:

  • Interviewers want to know you’re passionate about working for their company, not that you are just looking for A JOB.
  • Soft skills, such as good communication and interpersonal skills, and a collaborative personality are key. Be able to give examples of your soft skills.
  • Regulatory affairs is rarely a first career. Networking and experience are necessary to enter this area.
  • Physicians may find entry into regulatory affairs through working for the FDA. Look for fellowships offered by the FDA. Gain experience by participating in clinical trials.
  • Physicians can also be involved in regulatory affairs as medical writers.

In a panel presentation on Dietary Supplements and OTC medicines, Steve Mister from the Council for Responsible Nutrition, told a cautionary tale about a company that was putting Viagra and Cialis in products without disclosing their presence. The responsible party ended up with a 3 year prison term. In another case, the Feds seized $2 million in DMAA (1,3 Dimethylamylamine) at Hi-Tech Pharma, after it discovered this stimulant was associated with cardiovascular problems. He also mentioned a website, www.keepsupplementsclean.org which provides information to consumers and industry on tainted products, recalls, and warnings. Supplements pertaining to weight loss, muscle

which provides information to consumers and industry on tainted products, recalls, and warnings. Supplements pertaining to weight loss, muscle enlargement and sexual enhancement have been more likely to be laced with prescription drugs and anabolic steroids.  Products claiming to be helpful for diabetes, cholesterol and pain control are becoming targets for tainting.

I wish I could have attended many more of the presentations and seminars. There were speakers from around the globe talking on a wide array of issues pertaining to developments in regulatory affairs. If you are curious about the scope of this conference, you will find a list of the sessions here.

In addition to this annual conference, RAPS offers various other resources for regulatory professionals. They have a prestigious RAC designation (Regulatory Affairs Certification) for those with a minimum of 1- 3 years of experience, which involves sitting for an examination. There is also an on-line certificate program for those wanting to increase their knowledge base. One can obtain a Regulatory Affairs Certificate in Medical Devices or Pharmaceuticals, or both. Each of these tracts has 4 required courses:

  • Ethics
  • Global Regulatory Strategy for the Medical Devices or Pharmaceuticals
  • Medical Devices or Pharmaceuticals: Definitions and Lifecycle
  • Role of the Regulatory Professional

You choose 5 electives from a selection of 29 courses, which include offering such as, Pharmacovigilence (drug safety), FDA law and regulations, Medical Writing, Pharmaceuticals: Advertising and Promotion in the US, Understanding and Managing the US Clinical Trial Process, and Regulation of Dietary Supplements.

For more information about regulatory affairs, please visit the RAPS website. If you become a member, you can participate in local chapter meetings, receive discounts on courses, books and conferences, and have access to the career center and job bank. The RAPS annual conference this year will be in Baltimore, Maryland, October 24 -28th, 2015.

 

 

 

 

 

 

 

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"Heather’s approach was great! She would listen to me and helped me appreciate who I am."

I remember when she said ‘do your resume before our next meeting’, I was about to push back but she gently nudged me along and I’m glad I did exactly what she wanted me to do. We also did interview prep via Zoom and I was offered a great job in UM. She has continued to follow up even after I was offered this job, helping me with pointers about negotiating. I will totally recommend the Doctors Crossing and Heather to anyone feeling stuck like me and looking for a great coach! Thank you Heather!

- Modupe Oladeinde, MD

Family Medicine
Tim O

The coaching I have had with you has been life changing."

You helped me find the courage to seek out leadership positions and become a medical director as well as a physician advisor. I am grateful we crossed paths and am a different person because of it. You have inspired me to "believe" in spite of my inner skeptic. I consider you one of my most important mentors and am proud to also call you a friend. This says a lot given the apprehension I felt when I took a chance with our first coaching session. Even though I have already made a successful transition, I still value your ongoing mentorship and can enthusiastically attest that the value of your services is tremendous!

- Tim Owolabi, MD

Family Medicine
Lynette Charity

“I was at a crossroads in my medical career. I asked myself, "Do I stay or do I go?" 

I met Heather at the SEAK conference. She and I revisited this question.  Did I want to quit being medicine completely? She helped me to identify my needs, wants, and my vision for my FUTURE, not just in medicine, but in life!!!

She was able to listen to my "ramblings" about becoming a stand-up comic, lounge singer and voice-over actor and translate them into action steps.  I chose to become a composite of all of these. Now I am a more confident, healthier, happier person. I credit this in its entirety to the tutelage I have received and continue to receive from Heather.  She cares. She listens. She was there for ME.  She will be there for YOU!

- Lynette Charity, MD

Anesthesiologist
Gail Miller

“I am forever grateful to Heather for helping me to recognize, I am more than just my M.D." 

Heather helped me understand that I am more than just a doctor and that my experiences in clinical medicine are valuable in so many arenas.  As a result I realized that there are other ways to use my background, still be able to help people and continue to challenge myself and grow.  To that end I discovered coaching - specifically health coaching.  I am on my journey becoming a health coach and truly loving it!

- Gail Miller, MD

OB/Gyn physician
Steve

“Thank you, Heather, for helping me transform my career, my faith and my life."

What started out as an initial thirty-minute consultation call turned into an amazing four-year journey that transformed my life, personally, spiritually and professionally. 

Heather helped me to discover my passions...by doing so, I discovered I still had a calling for medicine but it now came from a place of truth...

Today...my wife and I are opening our first concierge medicine clinic in a community we love. I’m actually excited to have the opportunity to practice medicine the way I believe it’s meant to be, with a focus on the doctor-patient relationship and an emphasis on faith. I know if I had not reached out to Dr. Fork, my life would not be where it is at today.

- Steve Lapke, MD

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Sue Zimmermann

“Heather gave me the confidence to create a new livelihood by following my heart."

She is incredibly knowledgeable about the range of careers available to physicians and provided me with advice and connections which I would not have found on my own.  From the start she encouraged me to step out of my comfort zone and try different things.  I was laid off unexpectedly in early 2017, and Heather gave me the confidence to create a new livelihood by following my heart and making decisions based on trust, not fear.  Now I am enjoying working part-time in a clinical setting in addition to teaching and writing.

- Sue Zimmermann, MD

Orthopedic Surgeon
Devki Patel

After months of struggling to find a non-clinical career that matched my values and passion, I stumbled upon Heather's website which truly changed my life."

Heather's insightful and personalized approach to career coaching made me think outside the box since she took the time to evaluate my personality, values, interests, and preferred lifestyle.

Through her encouragement, practical advice, and professional connections, I was able to find a non-clinical position at a state Medicaid agency that aligned with my passion for population health and serving low-income communities. In addition to her coaching sessions, Heather has built a community of like-minded physicians through her blog, and I feel honored to recommend her to friends and colleagues who seek to make positive changes in their professional and personal lives.

- Devki Patel, MD

Pathologist
Jay Macregor

Working with Heather ultimately helped me leave my job in corporate healthcare and find a path that was much more fulfilling."

My career was going reasonably well but I couldn’t shake this nagging feeling I could do better; or at least find a better long-term career fit.  

I was able to find a surgery job that better aligned with my goals and professional interests.  Additionally, Heather helped me start a consulting business which has allowed me to pursue a true passion: helping medical students, residents, and attendings surgeons navigate the challenges of high-stakes standardized exams.    

If you are reading this as a “Type A” surgeon who doesn’t think coaching is for you, I would encourage you to give Heather a shot.  I’m very glad I did!

- Jay MacGregor, MD

Colorectal Surgeon
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“I gained the confidence in myself to develop an action plan that blended the best parts of my experiences and interests into a cohesive career." 

Through our work, I learned to trust myself to make good decisions for my own future – something I hadn’t realized I was struggling with because as an emergency physician, I make life-changing decisions with patients every day. 

By feeding my creativity and interests in other realms of my professional life, I’ve found renewed compassion for my patients and myself, making every shift an opportunity to actually care for people. Thank you Heather. I really couldn’t have made these changes without your help!

- Liz McMurtry, DO

Emergency Medicine Physician
Amie

The simple truth is - Heather Fork totally helped me change my life."

I never would have had the courage to make the changes I’ve made without her unwavering support, wealth of knowledge and commitment. 

When I first started working with Heather, I was downtrodden...I’d been practicing medicine for 20+ years and yet had never quite found my place.  During the first year I worked with Heather, I left the practice I’d been working at, and recreated an entirely new professional purpose.

I’m now an executive and leadership coach, a university professor, and a Brené Brown Daring Way facilitator, and I have never looked back.  I love what I am doing more than at any other time in my professional life and I credit Heather with seeing in me what I was never able to see in myself, until now.

Don’t hesitate, don’t doubt yourself, schedule your time with Heather as soon as possible- she can help you reconnect to your purpose and reinvent your life.

- Amie Langbein, DO

Family Physician
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"After 30 years in academic medicine, I wanted a career change but had no idea where to start. Medicine was all I knew."

I signed up for coaching with Heather and it transformed my life. She helped me get clear on what I wanted my life to look like. We reviewed my skills, values, and strengths. She instilled hope in me that change IS possible after 50 years! 

The outcome is that I have created a life I love! I practice endocrinology part-time and own a life coaching business! Coaching with Heather is one of the best investments I have made in my life. 

- Karen Barnard, MBBCh, MPH

Endocrinologist and Life Coach
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"Heather was my source of hope during a time when I felt stuck and confused. She gave me the permission and confidence to reach higher than I believed I could."

After graduating from residency and starting a family, I lost sight of why I became a physician. I struggled to convince myself to stay in a career that was clearly the wrong fit for me and my family. My anxiety about work was at an all-time high when I reached out to Heather. She provided something that my mentors, friends, and family could not – rather than just offering career advice, she changed the way I think about my life so that I could understand how my career would fit into it. I realized I wasn’t ready to give up on medicine and eventually found a job in academic medicine. I finally feel that excitement for medicine that I used to feel when I was in training. More importantly, I feel like I can be the role model to my young daughter who may one day also face similar challenges between career and family. Thank you, Heather, for all your kindness, support, and skillful coaching! The experience was life-changing!

- Yuri Shindo, MD

Internal Medicine Physician
Camille Gardner-Beasley

"As a Physician, your personal and even professional needs are often overlooked. I learned how to prioritize my career goals by working with Dr. Heather Fork."

She taught me how to put into practice what I knew in theory, that taking care of myself was a priority. I learned to give myself permission to make the career choices that would give me the work-life balance I desperately craved and needed. The process of confronting fears and insecurities was a bit scary, but well worth it in the end. I am now a happier version of myself with a non-clinical job that I truly enjoy!

- Camille Gardner-Beasley, MD

Family Medicine
Anna testimonial

"After 10 years in outpatient family medicine I felt stuck and knew I needed a change but I didn’t know where to begin. Thankfully I found Heather and she guided me every step of the way."

She helped me carefully assess my interests, strengths and passions while also providing me with constructive changes to implement in my job search and resume. With Heather’s help, I just landed a fully remote UM position and I am also exploring coaching as well. Now I feel like the possibilities are endless and I’m excited for this next chapter in the nonclinical world! Thank you Heather for changing my life for the better.

- Ana Jacobellis, DO

Abbey

"I'm truly thankful to have had the opportunity to be coached by Heather, she is not only a resourceful mentor but a wise and supportive friend. I'm honored to recommend Heather to all my friends and colleagues."

I had been a practicing Internist for 20 years when I reached a point when I needed to make a serious change in my career path. While I enjoyed seeing patients, I was not satisfied with my life-work balance. My job was taking me away from my family and left me little time and energy to do other things that are important and meaningful to me. I came across Dr. Fork's podcast; The Doctor's Crossing Carpe Diem Podcast, it is such an informative and enjoyable podcast for any physician who wants to do more with their career and life in general. Then I had the pleasure to get career coaching from Heather, it was truly an amazing experience. Heather has broad knowledge of all the different career paths that are available for physicians, she is so insightful and very easy to talk to. She helped me clarify my goals, examine my own mindset and definition of success. Together we developed a clear plan and actionable steps to reach these goals. I eventually made a career transition to a remote non-clinical position that allows me to do meaningful work which aligns with my personal and professional goals and priorities.

- Abbey Awad, MD

Internal Medicine