The Arnold & Porter Knowledge Leader Series: Pharmaceuticals: Key Trends and Regulatory Developments in 2010-The Prospects for 2011
30 Threadneedle Street
London EC2R 8JB
Please join members of our London Office for a day of discussion and presentations highlighting the key developments and trends in the European Union and United Kingdom in the regulation of pharmaceuticals over the past year and identifying important areas to focus upon in 2011. Our panel of experienced speakers will examine the practical implications of recent and anticipated changes and how companies may need to adapt their practices in future. The seminar will provide informed comment on the following major topics:
- Clinical Research: The review of the Clinical Trials Directive, the position on registries and the transparency of clinical trial results, trends in GCP inspections and amendments and additions to the ABPI template agreements for trials within the UK NHS.
- Data Protection, Orphan Drug Market Exclusivity, and Paediatric Rewards: Current issues relating to Supplementary Protection Certificates, update on the application and interpretation of the rules on data protection and issues relating to Orphan drugs and drugs for paediatric use.
- Issues in Pricing and Reimbursement: Recent developments in relation to price transparency, reimbursement and the future of NICE
- Impending Changes in Pharmacovigilance: The new EU legislative Proposal, inspection trends, the MHRA's new enforcement strategy and plans for managing safety data in social media.
- Developments in Parallel Trade and Repackaging: Recent developments in parallel trade and repackaging with a focus on the future direction of competition law and the reform of Customs controls for goods in transit.
- Marketing and Promotion: An update on the EU Proposals concerning medicines information, the impact of the UK Bribery Act, the position on incentives to prescribe, changes to the ABPI Code of Practice and recent trends in MHRA/PMCPA complaints.