C5 will be holding its 2nd Annual Forum on European Pharmaceutical Regulatory Law on September 21-22, 2011 in Brussels, Belgium. The conference will provide attendees with practical and strategic guidance on the most current regulatory developments impacting on the pharma sector, including presentations on the following topics:
• Interpreting the pharmacovigilance rules and the impact on reporting obligations;
• Reviewing pharma regulatory requirements and the interaction with competition law;
• The inclusion of environmental aspects into the EU legislation on good manufacturing practice (GMP);
• Obtaining and maintaining an effective pricing and reimbursement structure;
• The evolution of regulation and the drug approval system in the 21st century;
• The do's and don'ts in multi-jurisdiction clinical trials: Where are we and where are we going?
• Adopting an effective product labeling model to combat anti-counterfeiting;
• 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;
• Avoiding product liability litigation by reviewing global labeling practices;
• The current U.S. approval process in light of recent regulatory and legislative developments;
• Overcoming obstacles to ehealth and personalized medicine;
• Successfully obtaining SPCs and extensions of regulatory data protection: Extending market exclusivity (panel session);
• Guidance on the regulations applicable to advanced therapy medicinal products; and
• Privilege and discovery in pharma litigation.
A post-conference workshop on "Adopting Effective Risk Management Strategies to Avoid Product Liability Claims," will be offered from 9:00 am to 12:30 pm on September 23, 2011. The workshop will provide in-depth guidance on devising strategic risk management plans to ensure that internal processes and drug standards comply with drug safety requirements across Europe and the U.S., and equip attendees with the practical and strategic tools needed to obtain sustainable market access in Europe and the U.S. to avoid costly product liability claims.
The agenda for the European Pharmaceutical Regulatory Law Boot Camp can be found here. A complete brochure for this conference, including an agenda, description of the sessions, list of speakers, and registration form can be downloaded link.
The registration fee for this conference is €1899 (conference alone) or €2398 (conference and workshop). Patent Docs readers who reference the discount code "PD 200" will receive €200 off the current price tier when registering. Those interested in registering for the conference can do so here, by calling +44 20 7878 6888, or by faxing a registration form to +44 20 7878 6885.
Patent Docs is a media partner of ACI's Forum on European Pharmaceutical Regulatory Law.
Comments