Regulatory Affairs for Support Staff
This two day course which has been designed specifically for those working in a support staff role provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development.
Why you should attend
This two day course has been designed specifically for those working in a support staff role. It provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development. You will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market. Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products.
An Overview of Pharmaceutical Regulatory Affairs for Support Staff.
Key Topics to be covered:-
- Understand the Background of EU Law – Regulations, Directives and guidelines
- Discover where you can find information on regulatory affairs, approvals, withdrawals etc
- Assess the impact of the EU Clinical Trials Regulation
- Gain an Understanding of the Common Technical Document
- Discuss how to apply for a marketing authorisation in the EU – the Centralised, Decentralised and Mutual Recognition Procedures
- Clarify Post Authorisation Obligations – Pharmacoviglance, variations and renewals