An overview of pharmaceutical regulatory affairs for support staff
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. 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. The course will provide a thorough grounding in the subject of Regulatory Affairs and enable you to perform in your role more effectively.
Key Topics to be 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
* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Programme - Day one
European Law – Regulations, Directives
- Impact of Brexit
- Where can we find the information on regulatory affairs, approvals, withdrawal?*
- 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 Regulation*
- What is the process for running clinical trials in Europe?
Seeking scientific advice in Europe
- What are the processes?
The Common Technical Document
- Structure and content of a CTD
The European Medicines Agency
- Impact of Brexit
Impact of Brexit
Programme - Day two
Applying for a Marketing Authorisation in the EU with 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 Bexit
Managing product labelling
- Company core data sheets
- Updates to Summary of Product Characteristics
Post Authorisation Obligations; Pharmacovigilance, variations and renewals including discussion on the impact of Brexit
Pharmacovigilance and GCP inspections
- Type I and Type II variations
- Procedures and timelines
CASE STUDY 3 Renewals
Managing and supporting a regulatory affairs department
- Things to consider
- Maintaining oversight
Ms Norah Lightowler,
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.
This course is specifically designed for anyone working in Regulatory Affairs, including personal assistants, secretaries, administrators 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 who provide support to the Regulatory procedures and activities.
Venue to be announced shortly.