The Regulatory Affairs in Biosimilars 2015 covers topics such as:
- 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
The Regulatory Affairs in Biosimilars 2015 brings together senior attendees with responsibilities in:
- Market Access, Government
- Regulatory Affairs
- Strategic Development
- Relations, Economic Affairs
- Corporate Affairs
- Biosimilars Business Units
- Registration Affairs
