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EU (European Union) Pharmaceutical Regulations & Strategy Training Course
This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.
Details
Course Overview
Creating and coordinating an effective regulatory strategy is an essential part of the work of a regulatory affairs department and can save valuable time and money.
This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation. The impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical markets in Great Britain and Northern Ireland will be discussed.
The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well as an overview of the format for presentation of data, the registration procedures and post-authorisation obligations and strategic considerations. The impact of post-Brexit changes on obtaining and maintaining marketing authorisations in the UK will be discussed.
Case studies and discussion sessions throughout the two days will explore options and strategies for key regulatory activities and will provide an opportunity to share experiences with our expert trainer and other delegates.
Benefits of attending
- Understand the legal basis of the EU regulatory environment
- Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
- Discuss the impact of Brexit and consequent changes
- Discuss development strategy and pre-submission activities
- Discuss post-authorisation obligations and strategic considerations
Who should attend?
The course is designed primarily for regulatory affairs personnel, however it will also be of value to those who interact with the regulatory affairs function in order to gain an understanding of action timelines and information requirements. It will be particularly relevant to all those working in:
- Regulatory affairs
- Project management
- Business planning
- Commercial management
- Manufacturing and QA
- Labelling and artwork
- Medical information
- Clinical
- Pharmacovigilance
Programme
EU regulatory environment: legal basis
- Key regulations, directives and guidelines
- Impact of Brexit
Information sources
Case study one
Development and Strategy
- Drug discovery
- Scientific advice
Development process
- Pharmaceutical R&D
- Non-clinical tests
- Clinical studies - Phase I to III
EU Clinical Trials Regulation
Types and categories of marketing Authorisations
The Common Technical Document (CTD)
- Overview of Structure and content of a CTD
The European Medicines Agency (EMA)
- Structure and function
Applying for a marketing authorisation in the EU with discussion on the impact of Brexit
- The EU centralised procedure for marketing authorisation
Other EU centralised procedures
- Referral and arbitration
Other registration procedures
- Coordination group
- Decentralised procedure
- Mutual recognition procedure
- National procedures
Managing product labelling
Case study two
Abridged applications and Generics
- Types and Requirements
Product Life Cycle; Post approval
Patents and SPCs
Parallel trade
- How the process works
- Impact of Brexit
Post-authorisation obligations; pharmacovigilance, variations and renewals
Pharmacovigilance and GCP inspections including discussion on the impact of Brexit
Licence variations
- Type I and Type II variations and timelines
- Procedures and timelines
Extensions
Case study three
Renewals
Sunset clause
Phase IV Trials
Classification change
Generic development
Strategic factors
Criteria for successful products
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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18-19 Oct 2022 Live webinar 09:15-17:00 UK (London) |
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18-19 Oct 2022 Live webinar 09:15-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 13 Sep* |
Enrol now
to attend Live webinar |
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20-23 Feb 2023 Live webinar 13:30-17:00 UK (London) |
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20-23 Feb 2023 Live webinar 13:30-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,869 1,589 USD 2,129 1,817 Until 16 Jan 23* |
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to attend Live webinar |
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13-14 Jun 2023 Face-to-face, Rembrandt Hotel London |
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13-14 Jun 2023 Face-to-face Rembrandt Hotel London |
GBP 1,499 1,299 EUR 2,149 1,869 USD 2,449 2,137 Until 9 May 23* |
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to attend Face-to-face Rembrandt Hotel London |
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16-17 Oct 2023 Live webinar |
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16-17 Oct 2023 Live webinar |
GBP 1,299 1,099 EUR 1,869 1,589 USD 2,129 1,817 Until 11 Sep 23* |
Enrol now
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.