| Speakers: |
Kimberly Belsky, MS, director, policy and communication, global regulatory affairs pharmaceuticals, Bausch + Lomb
Linda Bowen, MS, RAC, senior director of policy and intelligence, global regulatory affairs, Sanofi-Aventis
David Hitchcoff, principal, SAI Med Partners
Belsky
is the director of policy and communication, global regulatory affairs
pharmaceuticals at Bausch + Lomb and has held positions of various
levels at Schering-Plough and Wyeth (now Pfizer). She has 20 years’
pharmaceutical experience, a broad understanding of the pharmaceutical
industry and the challenges it faces. Belsky began her career in
research and development and technology transfer, moved into a quality
control position assessing out-of-spec results and then transitioned
into drug development where she managed a GMP auditing function. For
the past 11 years, Kim has held a regulatory role with global
responsibilities that include advertising and promotion, labeling,
information management, auditing and regulatory intelligence. Kim holds
a master’s degree in chemistry from SUNY Stony Brook and has several
scientific publications. She is also a member of RAPS and DIA.
Bowen
is senior director of regulatory intelligence and policy at
Sanofi-Aventis and has held senior regulatory positions at Bayer
Healthcare and GlaxoSmithKline (via acquisition of Block Drug Company).
She holds an MS in drug regulatory affairs from the Arnold & Marie
Schwartz College of Pharmacy, where she was inducted into the Rho Chi
Society. She is regulatory affairs certified (RAC) for the US, Canada
and Europe. Bowen is a member of DIA, RAPS, the RAPS Board of Directors
(2-term), Chair of the RAPS NJ/NY Chapter, past chair of the RAPS
Annual Conference global briefings track and the first Canadian RAPS
Conference, a contributing author in RAPS,Choosing the Right Regulatory
Career and co-author of Regulatory Focus magazine articles on
regulatory intelligence tools. She has spoken at numerous RAPS and DIA
conferences and events. She is past chair of the Regulatory
Intelligence Network Group, a working group under the DIA Regulatory
Affairs SIAC and is an adjunct professor in Temple University's QA/RA
program.
Hitchcoff is currently a principal at SAI
Med Partners, a consulting firm that provides competitive intelligence
and strategic consulting to multiple healthcare sectors including
pharmaceuticals, biotech, consumer products and medical devices. His
responsibilities include business development, project oversight,
training and education. Hitchcoff has more than 14 years of consulting
experience including Pro-Trainer and the Gould Inc. Corporate
Management Consulting Team. Previously, he held various line management
positions with global medical instrumentation and device firms spanning
more than 20 years. These included vice president of marketing, vice
president of sales and marketing and vice president of regulatory
affairs. Hitchcoff is a member of The Society of Competitive
Intelligence Professionals (S.C.I.P.) and RAPS. He authored “The
Ethical Collection of Competitive Intelligence,” published in
Regulatory Focus magazine.
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