SOURCE: Parenteral Drug Association (PDA)

August 07, 2006 07:00 ET

2006 PDA/EMEA Joint Conference Focuses on "Understanding the European GMP Environment" 12-13 October 2006, London, UK

BETHESDA, MD -- (MARKET WIRE) -- August 7, 2006 -- The Parenteral Drug Association (www.pda.org) joins with the European Medicines Agency (EMEA, www.emea.eu.int) in London 12-13 October 2006 to address "Understanding The European Good Manufacturing Practices (GMP) Environment."

Key conference presenters include Thomas Lönngren, Executive Director, EMEA and Emer Cooke, Head of Inspections Sector, EMEA.

The conference will feature representatives from each of the EU Member States, including leading scientific, regulatory and legislative speakers from the Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Sweden, Switzerland and the United Kingdom. These speakers will examine global GMP considerations and perspectives in an interactive forum.

Celebrating its 60th anniversary in 2006, PDA is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. EMEA's main responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities.

"We are very pleased to participate in this joint conference with EMEA," said Robert Myers, PDA President. "The main objective is to provide a neutral forum for EMEA to communicate its views on various global topics to the pharmaceutical industry leaders who are manufacturing products under the Agency's regulatory authority."

Opening Session: Understanding the EU Regulatory Framework

Tim Marten of AstraZeneca UK chairs the opening session of this two-part presentation, which will lay out the foundations on which GMP in the European Union is based, starting with the legal origins of Directives and Regulations and how legislation is made in the EU. Participants will learn how law making occurs and how it is then implemented in the Member States.

The responsibilities of Europe's various review and oversight organizations will be described, including the role of the EMEA, and how it interacts with national bodies. The EU Commission and the European Directorate for the Quality of Medicine (EDQM) will be explained. Various options for making regulatory submissions, and the consequences for inspections, will also be clarified. The processes of carrying out GMP inspections, both domestically and overseas and how and when they occur sets the scene for the rest of the conference.

Sessions Focus on EMEA's Contribution to Good Manufacturing Processes (GMP)

Breakout sessions include, "Legislation and How it is Made," Martin Terberger, European Commission; "Regulatory Framework and Key Players," Emer Cooke, EMEA; "Inspections and How They Occur," David Cockburn, EMEA; "European GMP and its Implementation in Member States," Gerald Heddell, MHRA; "New Member State Agency Implementation of EU GMP," Milan Smíd, State Institute for Drug Control; "Industry's Role in the Development of Regulatory Controls," Stuart Heir, Novartis.

Preceding the Conference, 10-11 October, PDA's Training and Research Institute will offer two days of complementary training courses on Manufacturing Requirements for EU and US markets, risk management, quality systems strategies, and risk estimation in aseptic processing.

Full details are available at www.pda.org/pdaemea2006.

About PDA

The Parenteral Drug Association (www.pda.org), Connecting People, Science and RegulationSM, is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. As a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide.

About EMEA

European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonisation.

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