FDAAA serves FDA alumni by providing communications, holding functions, listing opportunities, and much more. Serving those who have served also takes the form of helping those who still are serving, the current staff at FDA.
Our Next Luncheon November 6
We are delighted that our next luncheon speaker will be Celia M. Witten, Ph.D., M.D. Celia is CBER's Director of the Office of Cellular, Tissue, and Gene Therapy. At the lunch she will highlight what is new at OCTGT and also talk about where the FDA sees the opportunities and challenges for cell and gene therapy. Since so many more companies are getting into this gene and cell therapy space and the National Academies of Science is hosting a global conference on gene editing in December this is a timely talk. Sign up now!
- When: November 6 from 11:45-1:30
- Where: Far East Restaurant, 5055 Nicholson Ln, Rockville, MD 20852; Upstairs
- RSVPs: Cut off is November 3rd, but if we get enough interest we will get the big room so please RSVP earlier
- RSVP to Alan Andersen at: firstname.lastname@example.org
- Cost : $25 per FDAAA member/ associate member: Guests will be charged $40. Please consider paying by Paypal in advance of the event.
- Food: It will be the usual family style meal; there will be vegetarian options (menu already chosen)
Frances Oldham Kelsey, MD, PhD, perhaps the best known FDAer, has passed away at the age of 101. Famed for her work in preventing a thalidomide tragedy in the U.S., she was awarded the President's Award for Distinguished Federal Civilian Service by President Kennedy, becoming the second woman to receive that award. Dr. Kelsey remained at FDA for many years after the thalidomide episode and is still acknowledged as a national hero.
We would like to post personal memories and tributes to Dr. Kelsey on the FDAAA web site. Please send your personal memories, or your reflections on what Dr. Kelsey meant to FDA and to consumer protection, to Wayne Pines (email@example.com) and he will collect them and post them.
Personal memory from Wayne:
"I have perhaps the strangest memory of Dr. Kelsey. She used to visit me often when I was at the agency, because she headed scientific investigations and we used to receive media inquiries about investigators. I don't recall any single specific substantive conversation about an investigation, but I do recall many discussions about the fact that she had to park her car on the street because she was not entitled to a parking space in the Parklawn Building or even in the outside lot, which was largely for car pools. There was nothing I could do to get her a parking spot, and she never expressed a sense of entitlement (she was personally humble), but she freely shared her sense of inconvenience. My strange memory of FDA's national hero"
An informal FDAAA happy hour and dinner was held at Taylor's Neighborhood Restaurant in Ocean Pines, MD on July 29. Thanks to Mark Elengold for organizing and sending in the photo. See if you know who's in the photo:
Seated, left to right - Gerry Meyer (OC, CDER), Brenda Meyer, Jeanne Deavers White (ORA, OC), Phil White (ORA, OC), Bob Bell (OC, CDER), Harriet Bell (Bureau of Drugs)
Standing, left to right - Richard Lipov (CDER), Jeri Lipov (CBER), Mark Elengold (ORA, OC, CVM, CDER, CBER), Bill Purvis (ORA, CDER, CBER)
This summer's event is part of the FDAAA's initiative where we are encouraging FDAAA members to plan and host a fun, budget-neutral get together with fellow alumni. Snap some photos, identify who is in it and a short write up and we'll post it on the FDAAA website. If you are interested in organizing a get together and want to know more, please contact Anne Marie Finley (firstname.lastname@example.org).
By Ekopimo Ibia, MD, MPH
Over the last decade, there have been widespread activities by nations, nonprofits, and industry to optimize global regulatory capacity, particularly in low and middle-income countries (LMICs). At the 51st Annual DIA meeting recently held in Washington, D.C., FDAAA International Network (FDAAAIN) hosted a session to highlight some of the progress made to date and opportunities for further improvement in global regulatory capacity.
Ekopimo Ibia, MD, MPH, FAAP (Co-Chair of FDAAAIN and Director, Medical Safety Review, Merck & Co., Inc.) chaired the session, titled "Progress Report on Emerging Nations and Regulatory Capacity Building." Highlights of the session included (a) the evolving effort to establish good reliance practices as an international best practice for a more efficient use of available global regulatory capacities, (b) the commendable progress toward setting up functional Regional Centers of Regulatory Excellence (RCORE) in sub-Sahara Africa, and (b) the recommendation for a systems approach to dealing with the challenges inherent in regulatory optimization efforts.
Former FDAer Dr. Murray (Mac) Lumpkin, MD, MSc (Deputy Director, Regulatory Affairs, Lead Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation, USA) kicked off the session with a presentation on regulatory systems optimization in LMICs. A major challenge in such countries, he said, is that the pharmaceutical access systems are often "open," loosely regulated, multifaceted, and complex with insecure supply chains and significant gaps in capacity, leading to long delays in patient access to quality medicines, and resulting in products of uncertain quality, safety, and efficacy being readily available to patients.
The FDAAA International Network (FDAAAIN) participated actively at the 2015 China Drug Information Association(DIA) Annual Meeting in Shanghai.
FDAAA is fortunate to have a very active and engaging International Network. The FDAAA provides a platform for the Network to conduct its many activities. The stories from Shanghai highlight the members of the Network - contact any of them for more information.
Here are the links to four stories and photos from the Shanghai meeting:
New! FDAAA Annual Report 2014
See a summary of 2014 of the year
For your Alumni Association
Opportunity: RAPS Seeks Regulatory Experts
The Regulatory Affairs Professionals Society (RAPS) is seeking senior/executive regulatory affairs experts to volunteer in updating the regulatory professional competency framework.
Interested FDAAA members should contact Cindy Karst at email@example.com (phone 301.770.2920). When contacting RAPS, applicants should indicate their area(s) of expertise and preference for one of the two work groups (the small group of assessors or larger group of validators).
Recent FDAAA Events
- FDAAA International Network visits with CFDA Officials and BioBAY Entrepreneurs (08/03/15)
- Dr. Florence Houn Receives DIA China Excellence in Service Award (08/03/15)
- FDAAA International Network Expands Footprint at 2015 DIA China Annual Conference in Shanghai China (08/03/15)
- FDAAA International Network hosts an "FDAAA and Friends Night" event in Shanghai (08/03/15)
- FDAAA International Network Featured at 51st Annual DIA Meeting (08/01/15)
- Andrew Bonanno Receives FDA Distinguished Alumni Award (06/29/15)
- Michael Taylor Receives FDAAA Wiley Award (06/28/15)
- FDAAA Launches New Year at Annual Meeting (04/20/15)
- FDAAA Elects New Board Members, Names Officers (04/20/15)
- FDAAA Luncheon with FDA CDER Center Director, Janet Woodcock, MD, April 2, 2015 (04/10/15)