| An FDC-Windhover webinar |
How to Prepare for the EU’s
Sweeping New Pharma Legislation
Wednesday, Jan. 21, 2009
11 am ET • 8 am PT • 4 pm WET • 5 pm CET • 90 minutes
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LIVE from the United Kingdom and Brussels!
Breaking Alert: European Commission Proposes Sweeping Changes to EU Pharmaceutical Legislation
In December, the European Commission proposed far-reaching changes to EU pharmaceutical legislation, including:
- The first systematic overhaul of the EU’s pharmacovigilance framework
since 1965
- New rules clarifying what information about prescription medicines pharmaceutical
companies can provide to the general public
- The introduction of new legislative provisions to combat counterfeiting of medicinal
- products
If adopted, the proposals will have a major impact on how pharmaceutical companies do business in Europe. Pharma companies will need to update their pharmacovigilance processes related to roles and responsibilities, adverse drug reaction case reports, periodic safety update reports and much more. Companies will also want to review their policies for disseminating information about medicines to ensure compliance with the new EU rules and to harmonize the information they provide in different EU member states.
Additionally, all supply chain operators will need to comply with stricter requirements aimed at combating counterfeiting, including new provisions regarding product safety features, controls and audits of suppliers, and additional inspections – some of which may hamper trade.
The proposals provide for a broad range of amendments to Directive 2001/83/EC on medicinal products for human use, and Regulation (EC) No. 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMEA). The suggested changes will now be sent to the Council and the European Parliament for review, amendment and adoption.
The Commission also adopted a vision for the European pharmaceutical sector that outlines initiatives the Commission will pursue in the near future. These include further improvement of a single and sustainable market in pharmaceuticals, taking on the opportunities and challenges of globalization, and making science deliver for European patients.
Find out how these breaking developments will affect your business strategy in Europe. Join Sidley Austin and Elsevier Business Intelligence — publishers of "The Pink Sheet" and IN VIVO — for a thought-provoking analysis of this brave new world, live from the U.K. and Brussels. Grab your team, a phone and a computer with Web access (that last one's optional). No travel required!
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MAURITS J.F. LUGARD is a partner in Sidley’s Brussels office, where he leads the EU Life Sciences Regulatory team. He advises on a variety of EU life sciences regulatory issues concerning food, drugs, medical devices, cosmetics, biotechnology, and chemicals. Recent areas of advice include food safety, pharmacovigilance, GMP compliance, post authorization safety studies, clinical trials, and the proposed EU Cosmetics Regulation.
Prior to entering private practice, Mr. Lugard gained nine years of regulatory and legal experience at the European Commission. During a three-year term at the European Commission’s Legal Service, Mr. Lugard advised on health and safety related trade barriers. In particular, he dealt with sanitary and phytosanitary (SPS) measures and technical barriers to trade (TBT). Mr. Lugard was responsible for analyzing draft legislation prepared by the Directorate-General for Environment and the Directorate-General for Health and Consumer Protection, including amendments to the EU Cosmetics Directive. He was also lead EU counsel for the negotiation of the Cartagena Protocol on Biosafety (on transboundary movement of genetically modified organisms and GMO foods) and was the European Commission’s legal counsel on its Communication on the "precautionary principle".
Mr. Lugard also spent six years at the European Commission’s Directorate-General for Enterprise, where he led the European Union’s "de-regulation" efforts in Japan for EU industrial products (including cosmetics, medical devices, food and drugs) and was a Commission negotiator on EU import limits for Japanese automobiles.
Mr. Lugard speaks widely on EU life sciences regulatory issues and features prominently in the rankings of the leading bar publications, including The Legal 500 Europe, Middle East and Africa. Mr. Lugard is "highly recommended" by PLC Cross-Border Life Sciences Handbook 2007/08. |
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| LAURENT RUESSMANN is a partner in Sidley’s Brussels office where he focuses on EU regulatory and international trade law.
Mr. Ruessmann has experience advising clients on a wide range of EU and international regulatory matter, including anti-counterfeiting. He also advises on EU environmental law, including chemical regulation under REACH, as well as on issues related to product safety, data privacy and intellectual property rights.
He assists clients in a broad range of international trade and customs matters under EC and Member State legislation, as well as under the WTO agreements. His trade law work also involves advice and representation in connection with EC anti-dumping, anti-subsidy and safeguards procedures and litigation, as well as various other EC, WCO and WTO trade and customs matters, including investment and market access issues, anti-fraud investigations, export controls and economic sanctions and issues related to preferential trade agreements, customs tariff treatment and duty recovery, and dispute settlement.
Mr. Ruessmann has worked with clients in a variety of industries, including pharmaceutical and chemical products, agriculture and food products, automobiles and auto parts, aviation, iron and steel products, metals, textiles and non-wovens, computers and accessories, other electronic equipment, other durable goods and equipment, consumer products, and banking and financial services. |
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Elsevier Business Intelligence
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