DUBLIN–(BUSINESS WIRE)–The “EU (European Union) Pharmaceutical Regulations & Strategy Training Course (Mar 2nd – Mar 3rd, 2026)” training has been added to ResearchAndMarkets.com’s offering.
This interactive course will provide an overview of the current European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation. The proposed EU pharmaceuticals legislation changes will be discussed in the relevant sections.
In the highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is crucial for ensuring compliance, maintaining market authorisations, and effectively managing drug development and post-approval obligations. Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where a comprehensive understanding of pharmaceutical regulatory affairs becomes indispensable.
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. It is therefore important to be aware of potential changes which may impact on strategy.
The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well a brief overview of the format for presentation of data, the registration procedures for obtaining marketing authorisations and post-authorisation obligations and strategic considerations.
The UK is no longer part of the EU but knowledge of interactions and collaboration with the EU and other regulatory agencies are important for obtaining and maintaining marketing authorisations in the UK. Case study sessions will explore options and strategies for key regulatory activities and provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.
Benefits of attending
- Understand the legal basis of the current EU regulatory environment
- Outline the background to and the proposed EU pharmaceutical legislation changes
- Discuss development strategy and pre-submission activities
- Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
- Discuss post-authorisation strategic considerations and obligations
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 and would benefit from 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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Key Topics Covered:
Day 1
EU regulatory environment: legal basis
- Key regulations, directives and guidelines
- Proposed EU pharmaceuticals legislation changes Information sources
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
Adaptive marketing authorisation procedures
The Common Technical Document (CTD)
- Overview of Structure and content of a CTD
Procedures for obtaining a marketing authorisation in the EU and EMA
- The EU centralised procedure
Other EU centralised procedures
- Referral and arbitration
Day 2
Other procedures for obtaining a marketing authorisation in the EU
- Coordination group
- Decentralised procedure (DCP)
- Mutual recognition procedure (MRP)
- 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
Post-authorisation obligations; pharmacovigilance, variations and renewals
Pharmacovigilance
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
Speakers:
Norah Lightowler
Lightowler Associates
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 training visit https://www.researchandmarkets.com/r/teu577
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