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biomedical-market-news.com_0013 - 2005-05-09 pda.org - sacserv.com/links.jsp mailto:acosta@pda.org 301-656-5900x158
From miw@fw5.sacserv.com Tue May 3 14:28:34 2005 [2005-05-03 14:28:34 125609]
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Date: Tue, 3 May 2005 12:48:02 -0500 (CDT)
From: E-mailNewsService <biomednews@aol.com>
Reply-To: E-mailNewsService <biomednews@aol.com>
To: chien@munged.ext
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?linkid699&subid412705&campid1554&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?linkid700&subid412705&campid1554&type=0

TO REGISTER ONLINE:

Complete the online registration form or register by fax visit:

http://sacserv.com/links.jsp?linkid701&subid412705&campid1554&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?linkid702&subid412705&campid1554&type=0
http://sacserv.com/links.jsp?linkid703&subid412705&campid1554&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?linkid704&subid412705&campid1554&type=0

Please forward this press release to colleagues who may want to read it.
-----------
EDITOR'S NOTE: The opinions, claims/statements in this press release are solely those of the author. The Medical Industry E-mail News Service(TM) & BMN Inc accept no legal liability/responsibility for its contents/transmission.

According to legal experts & federal requirements, this press release FULLY complies w/the CAN-SPAM Act, each of its provisions, & all applicable/current state/federal laws & regulations. This electronic newsletter & daily news transmittal service are Constitutionally-protected publications. Like the wire services, these are PAID transmittals of a news announcement & newsletter -- not an advertisement -- via the "Medical Industry E-Mail News Service(TM)." It's the world's 1st/largest, press release/newsletter distribution service focused exclusively on the medical product mfg industry.

ADD ME: If you/colleagues want to be added to this comp press release distribution list, please click below, or email: biomednews@aol.com
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READERSHIP: Pass-around e-mail forwarding generates a total readership of approx. 300,000-500,000 persons in almost 200 countries. Includes: valuable middle to top mgmt, key execs, decision-makers & regulatory affairs professionals at almost every US medical product mfgr/supplier & medical service provider. Over 800 leading medical trade associations, major universities, medical ctrs/hospitals, medical publishers, medical product mfg/service providers, law firms, regulatory organizations, US Federal Govt, & economic devel organizations, often use our E-mail News Service(TM).

TO ORDER: To place an order to transmit your press release to over 200,000 individual e-mail addresses of medical industry execs worldwide, please contact BMN Inc: jemailnews@aol.com or click below to charge your 1st order:
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Delete/Add/Change Requests: We honor all delete requests. To be removed from this distribution list, or to change/add your email #, please follow the simple instructions below. Or, forward the entire press release to: biomednews@aol.com & type: "Please Delete" in the subjectline. That way we can use computer coding at the tail end to correctly match it to your exact email #. Please allow 1-3 business days to take effect. Not asking to be deleted means that you consent to receive press releases & confirms there is an ongoing business correspondent relationship.

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