Attend this interactive course to gain a valuable introduction to pharmaceutical regulatory affairs and key responsibilities, essential for those in support or interactive roles.
Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where an understanding of pharmaceutical regulatory affairs is important.
This interactive course is designed for professionals in support or interactive roles, offering a valuable introduction to pharmaceutical regulatory affairs and their key responsibilities.
Participants will gain an overview of current and proposed changes to EU legislation and regulatory procedures necessary to register products in the EU and the regulatory activities required to maintain products on the market. The UK is no longer a member of the EU but interactions and collaboration with the EU and other regulatory agencies for obtaining and maintaining marketing authorisations in the UK will be discussed.
This course aims to enhance understanding of the role of regulatory affairs, enabling support staff to perform more effectively and efficiently.
Interactive discussion sessions and practical case studies will help to consolidate learning, providing attendees with the skills and knowledge to be effective in their roles within the pharmaceutical industry.
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
- Contribute to your Continuing Professional Development (CPD)
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Ms Norah Lightowler,
Lightowler AssociatesNorah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twentieth year of successful business. Norah has wide experience in the pharmaceutical and related neutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.
Who Should Attend
This course is designed for personnel wishing to gain an understanding of regulatory affairs in the pharmaceutical industry, including:
- Administrators
- Assistants
- Support Staff
It will also be of value to those who interface with the regulatory affairs function or support regulatory procedures and activities.
