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C5′s European Pharmaceutical Regulatory Law Intensive Course


European Pharma Regulatory Law

21-22 September 2011 | Brussels, Belgium

Intensive Course

Pharma companies have faced increased regulatory enforcement in Europe in the recent past. The Pharma Sector inquiry, combined with the impact of the EU Pharma Package have meant that European companies must continually adopt new processes, strategies and reporting practices to comply with the obligations imposed under the amending legislation. In particular, the marketing of pharma products has become subject to an increasingly complex web of legislation and regulation, resulting in the need for further guidance from regulatory authorities on the use of social media in today’s global market.

The 2011 European Pharma Regulatory Law forum will focus on recent developments affecting the pharma industry in Europe and will also assess the impact of US developments on European companies. Our outstanding panel of experts will examine the crucial regulatory competencies needed to comply with the authorities and avoid potential sanctions. In addition, members from the key European and US regulators will address the fundamental amendments to the ever-changing rules and regulations.

C5’s 2nd Annual Forum on European Pharma Regulatory Law brings together eminent in-house counsel from the world’s largest pharma companies and their expert regulatory and legal advisors from a range of European jurisdictions and the US. Based on their first-hand experience, the distinguished panel will provide you with invaluable information and insights on regulatory developments with a particular focus on:

  • Interpreting the Pharmacovigilance rules and the impact on reporting obligations
  • Implementation of the UK Bribery Act and how pharma company practices will need to change
  • The rise in social media: balancing information to patients and advertising to ensure compliance
  • Obtaining and maintaining an effective pricing and reimbursement structure
  • The Do’s and Don’ts in Multi-jurisdiction Clinical Trials: Where Are We and Where Are We Going?
  • Reviewing your Pharma Regulatory Requirements and the Interaction with Competition Law
  • Adopting an effective product labelling model to combat anti-counterfeiting
  • Successfully Obtaining SPCs and Extensions of Regulatory Data Protection: Extending Your Market Exclusivity
  • Overcoming Obstacles to eHealth and Personalised Medicine
  • Guidance on the Regulations Applicable to Advanced Therapy Medicinal Products
  • Avoiding Product Liability Litigation by Reviewing your Global Labelling Practices
  • The current US approval process in light of recent regulatory and legislative developments

Be where your industry will be on 21st and 22nd September 2011 and don’t miss out on this unique opportunity to hear from and network with the key pharma regulatory authorities, industry specialists and legal experts.

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This entry was posted on Thursday, August 18th, 2011 at 3:28 pm and is filed under Legal Conferences. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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