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ISPE confirms keynote speakers for ISPE Aseptic Conference.

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January 30, 2014 - Thomas Arista, Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI, and Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER/OMPQ have been confirmed as keynote speakers at ISPE’s 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology. Conference will also feature top aseptic processing experts from FDA, Merck, Merck Vaccines, Genentech, Novartis, BiogenIdec, AstraZeneca, Boehringer-Ingelheim, and Eisai.

FDA's Thomas Arista and Rick Friedman Confirmed as Keynote Speakers at 23rd Annual ISPE Aseptic Conference


ISPE
600 N. Westshore Blvd., Suite 900
Tampa, FL, 33609
USA



Press release date: January 23, 2014

(TAMPA, FLORIDA, USA) – Thomas Arista, Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI, and Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER/OMPQ have been confirmed as keynote speakers at ISPE’s 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology. Mr. Arista and Mr. Friedman will join honorary chair Charlotte Enghave Fruergaard, PhD, Partner, Global Consulting, NNE Pharmaplan to open the two-day conference highlighting significant issues related to barrier isolation – RABS and aseptic processing technologies and disposables. The event will take place 24 – 25 February 2014 at the Marriott Wardman Park in Washington, D.C. USA.

“Preventing contamination of injectable drugs is critical to patient safety. ISPE is dedicated to advancing industry and regulatory understanding and collaboration on issues related to aseptic drug manufacturing processes through our signature Aseptic Processing Conference,” said ISPE President and CEO Nancy Berg. “This year’s event builds on the conversations from previous conferences to encompass the most up-to-date industry thinking on technology solutions, best practices and lessons learned in real-world case studies.”

In addition to Mr. Arista and Mr. Friedman, the 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology will feature top aseptic processing experts from FDA, Merck, Merck Vaccines, Genentech, Novartis, BiogenIdec, AstraZeneca, Boehringer-Ingelheim and Eiasi, among others, as speakers and discussion leaders.

The Conference will consist of presentations, discussions and case studies related to two distinct tracks:

Aseptic Processing Technologies and Disposables, led by Jörg Zimmermann, Director, Process Development and Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany, and Klaus Ullherr, Product Manager, Robert Bosch GmbH, Germany

Barrier Isolation and RABS, led by Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA and Ryan Hawkins, Vice President of Operations & COO, Cook Pharmica, USA

The conference will also feature an “Ask the Regulators” panel discussion, which will ensure that all delegates have an opportunity to have their regulatory questions answered before the conclusion of the conference.

For a full list of conference sessions, speakers and registration details, please visit www.ISPE.org/2014AsepticConference.  Members of the media may obtain credentials to cover the event by contacting dhould@ispe.org.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for more information.

For more information contact:
Danielle Hould
ISPE Membership Marketing Communications Manager
Tel: +1-813-960-2105, ext. 277
Email: dhould@ispe.org
www.ISPE.org
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