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Date: Tue, 3 May 2005 12:48:02 -0500 (CDT)
From: E-mailNewsService <biomednews@aol.com>
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Subject: BMN PRESS RELEASE: Impact Of Recent FDA Initiatives On The Global
Pharmaceutical Industry Audioconference
X-Sub-ID: 3412705
X-Camp-ID: 141554

BMN PRESS RELEASE
Contact: Victoria Acosta
PDA Manager, Audio & Web Conferencing
301-656-5900 ext 158 phone
acosta@pda.org


THE IMPACT OF RECENT FDA INITIATIVES ON THE GLOBAL PHARMACEUTICAL INDUSTRY
-- Richard Poska, Abbott Laboratories, Speaker
-- May 05 2005; 1:30-3:00 pm EDT -- Audioconference
http://sacserv.com/links.jsp?linkid=19699&subid=3412705&campid=141554&type=0


BETHESDA MD USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- MAY 03 2005 -- While generating US focused guidances, the FDA is also weaving its policy to fit within the International Conference on Harmonization (ICH). It will thus influence global regulatory strategies - leaving industry and regulators alike with the challenge of developing an appropriate compliance strategy that works in an increasingly global marketplace.

This audioconference will explore the challenges facing industry and regulators in implementing FDA quality initiatives and highlight opportunities for future improvement.

BY ATTENDING THIS AUDIO CONFERENCE, YOU WILL LEARN:

-- FDA's 21st Century Initiatives & how they relate to guidances
-- Industry reactions to key parts of the initiative
-- Anticipated paradigm changes of the FDA CMC review process
-- Opportunities for industry

SPEAKER:

Richard Poska is a Director in Abbott's Global Pharmaceutical Regulatory Affairs group. He has a BS in pharmacy from the Univ of Illinois College of Pharmacy, and has worked with solid dosage forms at both Searle Labs and Upjohn Co., before joining Abbott. His 20 years of technical experience includes solid dosage form research, production troubleshooting, process improvement and support, harmonization of excipients and processing, application of statistics for manufacturing controls, Puerto Rico liaison and FDA inspection administrator.

He is internationally known for his presentations and publications on tablet compressing operations, mixing uniformity and design of experiments and the application of microwave drying to pharmaceutical processing. He chairs the SUPAC Equipment Equivalents Steering Committee for the International Society of Pharmaceutical Engineers (ISPE) which won the VP's National Performance Review "Hammer Award" for building a government that works better and costs less.

WHO SHOULD ATTEND:

This 1.5 hour audio conference is targeted toward the busy pharmaceutical professional in the following areas:

-- Regulatory Affairs Managers & Professionals
-- Drug Product Development Managers & Professionals
-- Drug Substance Development Managers & Professionals
-- Manufacturing Managers
-- Quality Assurance Managers

WHEN & WHERE:

Conference materials and dialing instructions for this audio conference will be sent to you upon registration:

http://sacserv.com/links.jsp?linkid=19700&subid=3412705&campid=141554&type=0

TO REGISTER ONLINE:

Complete the online registration form or register by fax visit:

http://sacserv.com/links.jsp?linkid=19701&subid=3412705&campid=141554&type=0

UPCOMING AUDIO CONFERENCES:

FDA's Revised Guideline on Aseptic Processing

May 19 2005 -- 1:30-3:00 pm EDT

Speakers: John Grazal, AstraZeneca and Richard Johnson, Abbott Laboratories

DOWNLOAD THE FLYER:

http://sacserv.com/links.jsp?linkid=19702&subid=3412705&campid=141554&type=0
http://sacserv.com/links.jsp?linkid=19703&subid=3412705&campid=141554&type=0

SAVE THE DATE:

UPDATE: TASK FORCE FOR VIRUS FILTER CHALLENGE & NOMENCLATURE STANDARDIZATION

May 24 2005
Speaker: Kurt A. Brorson, PhD, FDA CDER and Gail Sofer, GE Healthcare
Registration will be coming soon.

MICROBIOLOGY FOR NONMICROBIOLOGISTS: ESSENTIAL MICROBIOLOGY IN PHARMACEUTICAL MANUFACTURE

June 02 2005
Speaker: Dr. Suraj B. Baloda, Millipore Corp
Registration will be coming soon.

Audio Conference on Nanotechnology
June 30 2005
Speakers: TBA

FOR FURTHER INFORMATION, PLEASE CONTACT:

Victoria Acosta
PDA Manager, Audio & Web Conferencing
PDA
3 Bethesda Metro Ctr Ste 1500
Bethesda MD USA 20814
301-656-5900 ext 158 phone
301-986-0296 fax
acosta@pda.org
http://sacserv.com/links.jsp?linkid=19704&subid=3412705&campid=141554&type=0

Please forward this press release to colleagues who may want to read it.
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