This puts greater emphasis on pricing strategy, with prices driven down to remain competitive and resulting in lower margins. It is therefore important for generic manufacturers to competently manage the regulatory approval and compliance process to keep costs down.
This 2-day course will provide you with strategic insight into key requirements for developing generics from a global perspective and an overview of the generics market; current trends and practices; and, future strategies for regulatory compliance. You will examine the process in the EU and US comparing and contrasting with examples and case studies. As well as learning about small molecules you will examine the regulatory procedures for biosimilars, the biological generic equivalent, which are growing year on year.
There will be time on this course to discuss the likely implications of Brexit on regulatory strategies for generics.
What will you learn?
EU and US regulations
Examine the impact of EU and US regulatory approval for generic products
Criteria for approval
Clarify the criteria for submitting generic applications in Europe and US
Produce a development plan
Enable creation of development plan for "Right First Time" generics
Patents and trademarks
Assess the major developments in patents and trademarks for global generics
Key market developments
Pinpoint key developments in market exclusivity
Who is this course for?
This course has been specifically designed to address the needs of:
- Regulatory Affairs Managers/Officers/ Assistants
- Compliance Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Documentation Managers
- Key contributors to submission procedures
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.