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Regulatory Affairs for Support Staff Training Course
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.
27-28 Sep 2022
Details
Course overview
Working in pharmaceutical regulatory affairs is a complex role, with involvement in the drug development stages to post-approval obligations and marketing.
This interactive course is designed for those working in a support staff role and 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 the EU and the regulatory activities that need to be complied with to keep products on the market. The impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical market in Great Britain and Northern Ireland will be discussed.
The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the impact of Brexit in these areas. 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
- Discussion of the impact of Brexit
- 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
- Assess the impact of the EU Clinical Trials 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 will also be of value to those who interface with the regulatory affairs function or provide support to the regulatory procedures and activities.
Programme
European law – regulations, directives and guidelines
- Impact of Brexit
Where can we find information on regulatory requirements?
- The internet
- Approvals and withdrawals
The drug development process
- Drug discovery
- Pharmaceutical R&D
- Non-clinical tests
- Clinical studies – Phase I to IV
Clinical Trials in Europe
- The EU clinical Trials Regulation
- Clinical trials in the UK
Seeking scientific advice in Europe
- Outline of procedures
Types of and categories for marketing authorisation of applications for approval
The CTD
- Overview of the structure and content of a CTD
The European Medicines Agency
- Functions and responsibility
Procedures for marketing authorisation in the EU with discussion on the impact of Brexit
The EU centralised procedures
- EU centralised procedure for marketing authorisation
- Referral and arbitration
Non-centralised procedures for marketing authorisation in the EU with discussion on the impact of Brexit
- Co-ordination group
- Decentralised procedure
- Mutual recognition procedure
- National procedures
Generic applications
- Types and requirements
Product Life Cycle; Post approval
Parallel trade
- How the process works
- Impact of Brexit
Post-authorisation obligations: pharmacovigilance, variations and renewals including discussion on the impact of Brexit
Pharmacovigilance and GCP inspections including discussion on the impact of Brexit
- Requirements and criteria
Licence variations
- Types and timelines
Extensions
Renewals
Sunset clause
Managing and supporting a regulatory affairs department
- Things to consider
- Maintaining oversight
Presenter
Norah Lightowler (More...)
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 twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, 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.
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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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27-28 Sep 2022 Live webinar 09:15-17:00 UK (London) |
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27-28 Sep 2022 Live webinar 09:15-17:00 UK (London) |
GBP 1,099 899 EUR 1,579 1,299 USD 1,786 1,474 Until 23 Aug* |
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to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.