This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
Working in pharmaceutical regulatory affairs is a complex role, with involvement in not only the drug development stages but also post drug-approval activities and marketing.
This interactive course, designed specifically for those working in a support staff role, provides a valuable introduction to pharmaceutical regulatory affairs and key responsibilities.
Participants will gain an overview of the 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.
The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the potential impact of Brexit. The course will provide a thorough grounding in the subject 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
- Consider the potential impact of Brexit
- Gain an understanding of the Common Technical Document n Discuss how to apply for marketing authorisation in the EU - the centralised, decentralised and mutual recognition procedures
- Clarify post-authorisation obligations - pharmacovigilance, variations, and renewals
- Assess the impact of the EU Clinical Trial Regulation
Who Should Attend:
This course is designed for anyone working in regulatory affairs including administrators, assistants and any member of support staff wishing to gain a greater understanding of regulatory affairs in the pharmaceutical industry.
It is also suitable for those who interface with the regulatory affairs function and provide support to the regulatory procedures and activities.
Programme - Day one
European law - regulations, directives, and guidelines
- Impact of Brexit
Where can we find information on regulatory affairs?
- The internet/publications
- Approvals and withdrawals
The drug development process
- Drug discovery
- Pharmaceutical R&D
- Non-clinical tests
- Clinical studies - Phase I to IV
Case Study 1
The EU Clinical Trials Directive and new Clinical Trial Regulation
- What is the process of running clinical trials in Europe?
Seeking scientific advice in Europe
- What are the processes?
- Structure and content of a CTD
The European Medicines Agency
- Impact of Brexit
Programme - Day two
Applying for marketing authorisation in the EU with a discussion on the impact of Brexit
- The EU centralised procedure
- Decentralised procedure
- Mutual recognition procedure
- National procedures
Case Study 2
- How the process works
- Impact of Brexit
Managing product labelling
- Company core data sheets
- Updates to the summary of product characteristics
Post-authorisation obligations: pharmacovigilance, variations, and renewals including discussion on the impact of Brexit
- What to expect
- Type I and Type II variations
- Procedures and timelines
Case Study 3
Managing and supporting a regulatory affairs department
- Things to consider
Norah 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.
For more information about this conference visit https://www.researchandmarkets.com/r/fez8n0