Regulatory Affairs in Biosimilars 2015

Topics

• Clinical Trials Regulations and Impact Industry/Regulators EC`s have in the EU
• Opportunities in Biosimilars development in evolving global regulatory landscape
• Pharmacovigilance in the EU with emphasis on biopharmaceuticals, PRAC activities update and post-approval efficacy studies
• Current regulatory requirements for Parallel Scientific Advise between FDA and CHMP
• Indian Regulations on Biosimilars

Who should Attend

Senior attendees with responsibilities in:

• Market Access, Government
• Regulatory Affairs
• Strategic Development
• Relations, Economic Affairs
• Corporate Affairs
• Biosimilars Business Units
• Registration Affairs