Second Pharmaceutical Regulatory Law Forum

April 8, 2011 - PRLog -- 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 obligationImplementation of the UK Bribery Act and how pharma company practices will need to change
   * The rise of social media: balancing compliance obligations with effective marketing strategies
   * Obtaining and maintaining an effective pricing and reimbursement structure
   * Combating the challenges in the clinical trials approval process
   * The interaction between competition law and pharma regulatory requirements
   *  Adopting an effective product labelling model to combat anti-counterfeiting
   * Identifying clinical risks and benefits to achieve successful Health Technology Assessments
   *  The approach to labelling negotiations and product liability litigation in Europe and the US
   * The current US approval process in light of recent regulatory and legislative developments

Read more about this at: http://c5-online.com/2012/633/2nd-european-pharmaceutical...

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