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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.
Upcoming Events
FDAAA Midwest Luncheon
As FDAAA continues to push its activities outside the beltway, in 2016 it is coming to Chicago, IL!
Come to our very first FDAAA Midwest Luncheon.
Meet some new faces and catch up with old friends!
- When: Friday, October 7, 2016, 11:45 AM - 1:30 PM
- Where: Trinity International University, 2065 Half Day Rd, Deerfield, IL
- Speaker: William (Bill) Weissinger, Director, Chicago FDA - District Office
- Cost: $20 members; $25 non-members.
- Please RSVP by 9/23/16 to terrance.ocheltree@abbvie.com
- Questions? Call Terry Ocheltree @ 224-358-1986
In Memorium: Ekopimo Ibia, M.D., M.P.H., MRCPCH, FWACP (Peds), FRCP
By the FDAA International Network Planning Group
Dr. Ekopimo "Imo" Ibia, co-chair of the FDA Alumni Association International Network (FDAAAIN), of which he was a founding member, passed suddenly on June 14, 2016.
Dr. Ibia was part of the original Planning Group of the FDAAAIN when it was established in 2009. He led activities and recruited FDA alumni with interest in international regulatory capacity building with a focus on Africa.
He authored many polices and strongly advocated the important role FDA alumni play in global regulatory capacity building. To that end, he contributed FDAAAIN public comments to the African Union on the 2014 Model Law on Medical Products Regulation and Harmonization in Africa and to the World Health Organization (WHO) on its 2016 Draft Good Regulatory Practices: Guideline for National Medical Products Regulatory Authorities. He participated in the African Regulatory Conferences sponsored by the Drug Information Association (DIA). He chaired sessions at US DIA on regulatory convergence and capacity building. In fact, he was to chair the FDAAA's 2016 US DIA session on June 21 entitled, Infectious Disease Containment and Lessons Learned, but because of his sudden illness, his co-chair, Jinjie Hu PhD, stepped in to assume that role. He envisioned a healthy, thriving Africa and contributed to processes and plans for good regulatory systems. He was selfless in tasks to advance the many important works of the FDAAA.
Dr. Ibia's job was Principal Scientist, Medical Safety Review at Merck & Company. He was formerly Director, Global Medical and Regulatory Policy there, and an adjunct professor at Johns Hopkins University, Baltimore, Maryland. Prior to joining Merck & Co., Dr. Ibia was a lead review medical officer at the United States Food and Drug Administration and attending pediatrician at Suburban Hospital, Bethesda, Maryland. Dr. Ibia also served as a board member of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas, Inc., Chair of its Website and Publication Committee and Co-chair of the Local Organizing Committee for the 2009 NAPPSA Scientific Conference and Exhibition. He was a co-Director of Bamboo Corale, Limited (BCI), a Nigerian consulting company. Through BCI, Dr. Ibia was supporting several projects in his homeland of Nigeria.
Dr. Ibia was certified both in pediatrics and pediatric infectious disease by the American Board of Pediatrics. Dr. Ibia was the recipient of several scientific awards and has published extensively in peer-reviewed scientific and medical journals.
He leaves behind his beloved family: wife Dr. Itoro E. Ibia, and 5 children (3 sons and 2 daughters), Atainyene, Yakayama, Imikomobong, Faith, and Salome. Our prayers and thoughts go to them. He was a true gentleman, scholar, and humanist whose laugh and smile are greatly missed.
Dr. Ibia (right), chairs a 2012 US DIA Session on Global Regulatory Capacity Building Efforts
FDA Celebrates 40th Anniversary of Medical Devices Amendments
It was 40 years ago, in 1976, when the Congress enacted and President Ford signed the Medical Device Amendments, which led to the creation of the Center for Medical Devices and Radiological Health.
On June 22, CDRH held a celebration to commemorate the occasion. CDRH now has 1,700 staffers compared to 180 in 1976.
Jeff Shuren, the CDRH director, spoke at the celebration and also posted a blog to mark the anniversary. In the blog, Jeff wrote: CDRH is "a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement."
Here is a link to the blog:
Pictured here are former CDRHers and current FDAAA members: (left to right) Jim Benson, Bob Sauer, John Villforth and David Feigel. (Jim, Bob and John all were intimately involved in the founding of both CDRH and FDAAA, while Dave served later as CDRH director.)
FDAAA Honors Three Leaders
FDAAA has presented awards to three alumni who have made significant contributions to the organization. The three photos depict Awards Committee Chair and Board Director Marie Urban (in all three photos) presenting the Founders Award to FDAAA President Ed Steele (Chair Nancy Myers looking on), the Certificate of Appreciation to Member Service Committee Chair Karen Carson, and the Service Recognition Award to Fredda Shere-Valenti, who recently retired from FDA and who has been active in FDAAA since its inception.
Spring Fling!
Each year the FDAAA sponsors a Spring Fling which attracts not only members from the FDAAA but also the senior leadership of the FDA. This year's May 18 event was no exception. New FDA Commissioner Robert Califf spoke about the agency and his plans moving forward.
FDA Seeking "Objective" Reviewers for Grant Funding
FDA's Office of Partnerships (HHS/FDA/ORA/OP) is actively looking for Scientific, Regulatory, and Public Health professionals to serve on Objective Review Board (ORB) panels to review, score, and comment on grant applications for the 2016 funding award cycle. Objective Review Boards are a mandatory process to award funding for FDA's grant and cooperative agreement programs. Prior service and experience on ORB panels is not required. Please note that these activities are an agency priority, as several of the grant and cooperative agreement programs are Congressionally-mandated.
To volunteer, please email your request with a current resume and the completed ORB Reviewer Questionnaire to Graham N. Giesen at op.reviewers@fda.hhs.gov.
Details on who can serve as an objective reviewer, how to apply and other information, including the Questionnaire, are available here.
FDAAA Members Are Updated on Combination Products
A great combination: Barr Weiner, Associate Director for Policy, OCP (left) and Thinh Nguyen, Director, Office of Combination Products (OCP)(right), offered FDAAA members insight into the increasingly important future of combination products and the collaborative cross-center efforts the FDA is implementing to meet future opportunities. The lunch took place at Mrs. K's Toll House in Silver Spring.
Combination drugs/devices/diagnostic products are becoming increasingly more common. They enable patients to be treated and diagnosed with multiple products that are designed and approved to be used together.
Thirty FDAAA members joined Thinh Nguyen, Director, Office of Combination Products (OCP), and Barr Weiner, Associate Director for Policy, OCP, for a lively luncheon discussion on April 8 about FDA's latest initiative in reviewing combination products.
Thinh and Barr gave a brief overview of OCP's current activities and then discussed some of the major "hot topics" in combination products, including the formation of a new combination products policy council, implementing "lean process" mapping, improved reviewer training, and forthcoming guidances and regulations.
Thinh and Barr were extremely generous with their time and willingness to engage. Their participation underscores the ongoing close relationship between FDA and FDAAA.
FDA Alumni Advisor Program a Big Success
The FDA Alumni Advisor Program Pilot ended on March 18, 2016 after a 9 month run which showed that the program met its objectives and was successful in bringing back retirees to mentor current employees. Plans are underway to turn it into a formal program in the fall of 2016.
FDAAA Contributes to WHO Guideline on Good Regulatory Review of Practices
By Florence Houn, MD
In 2015 World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations published its forty-ninth report, Annex 9, Good Review Practices: Guidelines for National and Regional Regulatory Authorities.
http://apps.who.int/medicinedocs/documents/s21902en/s21902en.pdf
This remarkable document contains the distilled wisdom of many regulators, experts, and the FDA Alumni Association (FDAAA). It is a simple primer for consideration by regulatory health authorities regarding the principles of good review practices (GRevP); management of the review, communications before, during and after review; review personnel; and the conduct of regulatory reviews of medical product applications.
The objective of the document is to provide high-level guidance on the principles and processes of good review practice (GRevP) for use across a range of regulatory authority (RA) maturities. It is not intended to provide detailed instruction on how to conduct a scientific review.
FDAAA Conducts Seminar for FDA Fellows
FDA alumni and FDAAA members conduct a panel for the FDA Fellows. From left are Bill McConagha, Susan Winckler, Nancy Myers, Jeanne Ireland, Mark Elengold, Florence Houn, and Wayne Pines.
FDA historian Suzanne Junod presents to the FDA Fellows a brief history of the Agency.
Steven Grossman of the Alliance for a Stronger FDA discusses the FDA budget.
FDAAA has conducted an annual educational seminar for the FDA Fellows for about half a dozen years. This year's session was on January 6 at White Oak.
The Fellows program provides a means of attracting and training future FDA employees. The Fellows work throughout the Agency during their program. FDAAA members Nancy Myers and Wayne Pines have organized the annual educational seminar at the invitation of the FDA.
The agenda in January 6 included a presentation by FDA historian Suzanne Junod summarizing the history of FDA; a panel of FDA alumni who discussed their experiences at FDA; and a presentation on FDA's budget by Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, an independent organization that has advocated on behalf of the. Agency's budget for the past decade.
The FDAAA members who participated in the alumni panel were FDAAA members Mark Elengold, Florence Houn, Jeanne Ireland, Bill McConagha, Nancy Myers, Wayne Pines, and Susan Winckler.
Some of the themes emphasized by the alumni were the importance of FDA work, the mission orientation of FDA employees, and the advantages of networking while working at the Agency.
The session was teleconferenced to Fellows unable to attend.
Reception for Chiefs of Staff
FDAAA sponsored a cocktail reception December 3 honoring FDA chiefs of staff (or their equivalents). The event took place at the offices of Covington and Burling in downtown D.C.
As you can see from the photos the event was well attended and gave the attendees a chance to mingle and reminisce. Acting Commissioner Stephen Ostroff joined the gathering.
Sponsors for the event included the Biotech Policy Group, Catalyst Healthcare Consulting, Covington and Burling, EAS Consulting, Greenleaf Health, Hogan Lovells, Keller and Heckman, and former FDAer and FDAAA member Dr. Murray Lumpkin.
This is the second year that FDAAA has sponsored a December reception for members. The 2014 reception honored former and current Center directors.
Former chiefs of staff (or equivalent) gather for a photo with FDAAA officers. See if you remember these faces and names: (left to right) Ed Steele (FDAAA), Tom Kraus, Susan Winckler, Tom Grumbly. Molly Muldoon, Stuart Pape, Acting Commissioner Stephen Ostroff, Joe Levitt, Lisa Barclay, and Nancy Myers (FDAAA).
Vacancy Announcements for Key Alumni Association Positions
The FDA Alumni Association is looking to fill the following three positions with members willing to contribute to the continued growth of the Food and Drug Alumni Association. These are senior positions within the leadership of the FDA Alumni Association. Each is an unpaid volunteer position, allowing incumbents to work with a dynamic team of former FDA leaders. Applicants must be an FDAAA Member in good standing. Applicants should be willing to devote several hours per month to the duties described below.
Links to Recent FDAAA Events and Announcements
Recent FDAAA Events
(06/27/16) (05/23/16) (05/23/16) (04/12/16) (01/09/16) (12/10/15) (11/06/15) (08/03/15) (08/03/15) (08/03/15) (08/03/15) (08/01/15) (04/10/15)Announcements
- FDA Celebrates 40th Anniversary of Medical Devices Amendments (06/21/16)
- FDA Seeking "Objective" Reviewers for Grant Funding (04/19/16)
- Vacancy Announcements for Key Alumni Association Positions (12/18/15)
- FDA and FDAAA to Collaborate on Pilot Alumni Advisor Program (04/17/15)
- Opportunity: RAPS Seeks Regulatory Experts (03/10/15)
- FDAAA Praises Hamburg for Her Dedication To FDA's Mission and Looks Forward to Working with Dr. Stephen Ostroff Who Will Serve as Acting Commissioner (02/05/15)