Regulatory Affairs for Support Staff

Working in pharmaceutical regulatory affairs is a challenging role, with involvement in the drug development stages, the marketing authorisation submission process and post-approval obligations and marketing.

This interactive course is designed for those working in a support or interactive role and provides a valuable introduction to pharmaceutical regulatory affairs and key responsibilities.

Participants will gain an overview of current and proposed changes to EU legislation and regulatory procedures required to register products in the EU and the regulatory activities that must be complied with to maintain products on the market. The impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical market in the UK will be discussed.

The programme also covers pharmacovigilance and safety reporting with sessions on licence variations and renewals. The course will provide understanding of the role of regulatory affairs and enable support staff to perform more effectively.

Discussion sessions and the use of case studies throughout the two days will help consolidate learning.

Benefits of attending:

• Understand the background of EU law – regulations, directives and guidelines
• Gain an understanding of the Common Technical Document
• Discuss how to apply for a marketing authorisation in the EU via the centralised, decentralised and mutual recognition procedures
• Clarify post-authorisation obligations – pharmacovigilance, variations and renewals
• Discuss the proposed EU legislation changes
• Contribute to your Continuing Professional Development (CPD)