3 June 2016
7:30 am–12:00 pm
CryoLife Headquarters
Kennesaw, GA
Join regulatory colleagues in the Atlanta/Southeast area for a morning of networking and a lively discussion on “The Role that Regulatory Intelligence Plays in a Highly Regulated Environment.”
In an ever-evolving regulatory/scientific/legislative environment, regulatory intelligence has become an essential tool in product development, risk minimization, label optimization and lifecycle management. Join us as we explore the role of the regulatory intelligence function, discuss the tools of the trade, review the process of gathering and analyzing publicly available information and delve into the world of regulatory intelligence metrics.
A light breakfast will be served. This event is sponsored by the RAPS Atlanta Chapter and is intended to facilitate networking among area regulatory personnel. RAC holders receive two recertification credits for attending this event.
Date/Time:
Friday, 3 June 2016
7:30–8:15 am Registration, Light Breakfast and Networking
8:15–11:30 am Speaker Presentation and Q&A Session
11:30–12:00 pm Optional Facility Tour
Location:
CryoLife Headquarters
1655 Roberts Blvd, NW
Kennesaw, GA 30144
Get directions online or call +1 770 419 3355
Registration:
Prior to 28 May
RAPS Members: $30 Nonmembers: $45
On or after 28 May
RAPS Members: $40 Nonmembers: $55
» Registration Form (PDF) - for registration by mail or fax, or call +1 301 770 2920 ext. 200.
Speakers:
Linda Bowen, MS, RAC, FRAPS, head of US regulatory science and policy, Sanofi
Alexander Gaffney, RAC, senior manager, Health Research Institute, PwC
Bowen is head of US regulatory policy and intelligence at Sanofi. She has held regulatory and quality positions at Bayer Healthcare and GSK (Block Drug), with global regulatory responsibilities for submissions, lifecycle management and due diligence activities. She has been working in the pharmaceutical industry for 30+ years.
Bowen attained regulatory affairs certification for the US, Canada and Europe, and was an inductee to the 2011 Class of RAPS Fellows. She was honored with the Drug Information Association's 2012 Excellence in Volunteer Leadership Award.
Bowen is a past two-term member of the RAPS board of directors and past chair of the NJ/NY RAPS Chapter. She is chair of the DIA Regulatory Affairs Community and founder of the DIA Regulatory Intelligence Working Group. She has sat on the planning committee for the 2012-2014 DIA Regulatory Information Management conferences, the 2013-2015 DIA annual conferences, and the 2011-2015 RAPS annual conferences. Bowen is a frequent speaker and author on various regulatory policy and intelligence topics.
Alexander Gaffney is a senior manager with PwC's Health Research Institute (HRI). Gaffney leads HRI’s analysis of regulatory and legislative policies impacting the life sciences industry and new entrants.
Prior to joining HRI’s regulatory center, Gaffney worked for the Regulatory Affairs Professionals Society (RAPS) where he led their regulatory intelligence unit. He has written extensively about the regulation of pharmaceuticals, biotechnology products, medical devices and dietary supplements, and his work has been cited in several congressional reports. He was also the managing editor of Regulatory Focus, RAPS’ news publication. Gaffney has his Regulatory Affairs Certification (RAC) in US regulation and is a graduate of Providence College in Providence, RI.
Local Contacts:
Penny Northcutt, RAC, FRAPS, chair, RAPS Atlanta Chapter
Sylvie Laliberté Verdon, MS, RAC, MPM, education committee, RAPS Atlanta Chapter
RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations, RAPS, +1 301 770 2920
Speacial thanks to our program sponsor: