Modifications in the EU law governing authorization of pharmaceutical products - The Cyprus clause, the new position of the innovative products and changes for the generic industry. The EU law governing authorization of pharmaceutical products has been substantially modified. The periods of market and data protection for innovative products have been clarified.
The possibilities of generic authorization have been evolving and have now been joined by 'biosimilars'. These changes will have important impact on the pharmaceutical industry.
The possibilities of generic authorization have been evolving and have now been joined by 'biosimilars'. These changes will have important impact on the pharmaceutical industry.
Areas Covered in the Seminar:
- The purpose of the legislative review
- The key changes in the modification
- The new position of the innovative products
- Changes for the generic industry
- What are biosimilars
- The Cyprus clause
- Pharmacovigilance
Who Will Benefit:
- In-house- legal counsels in the pharmaceutical firms
- Consultants/Advisors to the pharmaceutical firms
- The generic biosimilar industry
- Regulatory affairs professionals in the pharmaceutical firms
- Executive team in the pharmaceutical firms
Course Provider
Elizabethann Wright,
