Dublin, Nov. 13, 2026 (GLOBE NEWSWIRE) -- "EU Pharmaceutical Regulations and Strategy (Mar 1st - Mar 2nd, 2027)" has been added to ResearchAndMarkets.com's offering.
Pharmaceutical regulatory affairs professionals must remain current with evolving legislation, regulatory procedures and agency expectations to support compliance, protect market authorisations and manage drug development and post-approval obligations effectively. This interactive course provides a focused overview of the European pharmaceutical regulatory environment, including current requirements, emerging changes and their potential impact on regulatory planning.
Creating and coordinating an effective regulatory strategy can save significant time and resources throughout the product lifecycle. The course examines the procedures, methodologies and strategic considerations that regulatory affairs departments should evaluate when planning development programmes, preparing submissions and maintaining authorised products. Particular attention will be given to the agreed changes to EU pharmaceutical legislation, with discussion of anticipated implementation and transition timelines.
The programme covers the legal basis of EU pharmaceutical regulation and the principal considerations involved in developing a regulatory strategy. Delegates will explore development pathways, the value of pre-submission activities and the presentation of supporting data. The course also reviews registration procedures for obtaining marketing authorisations, together with the post-authorisation obligations that influence ongoing product management, compliance and commercial planning.
Artificial intelligence is becoming increasingly relevant across pharmaceutical product development, manufacturing and post-authorisation activities. The course considers the growing use of AI within these areas and highlights the regulatory and strategic issues organisations should assess when incorporating AI-enabled processes into pharmaceutical operations.
Although the UK is no longer part of the EU, it remains a major pharmaceutical market. Regulatory professionals therefore need a clear understanding of the relationship between UK and EU requirements, as well as interactions and collaboration between the relevant authorities and other international regulatory agencies. The programme addresses key considerations for obtaining and maintaining UK marketing authorisations while managing regulatory activities that may also involve EU procedures.
Case study sessions will allow delegates to assess practical options and develop strategies for important regulatory activities. These interactive exercises are designed to encourage informed discussion, critical evaluation and the exchange of professional experience. Participants will have opportunities to examine regulatory scenarios with the expert trainer and consider how different approaches may affect development plans, submission pathways and lifecycle management.
The course is suitable for professionals working in regulatory affairs, pharmaceutical development, quality, manufacturing, medical affairs, clinical operations and related functions. It will also benefit those who contribute to regulatory strategy or require a stronger understanding of European pharmaceutical legislation, EU marketing authorisation procedures and UK regulatory requirements.
By the end of the programme, delegates will have strengthened their knowledge of the European pharmaceutical regulatory framework, current legislative developments and strategic regulatory planning. They will be better equipped to evaluate procedural options, anticipate future obligations and support efficient decision-making across development, registration and post-authorisation activities.
CPD Hours: 12
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
Key Topics Covered:
- Day 1
- EU regulatory environment: background and legal basis
- Information sources
- Case study one
- Development and strategy including the use of AI
- Development process
- EU Clinical Trials Regulation
- Types and categories of marketing authorisations
- Adaptive marketing authorisation procedures
- The Common Technical Document (CTD)
- Procedures for obtaining a marketing authorisation in the EU and the EMA
- Other EU centralised procedures
- Day 2
- Other procedures for obtaining a marketing authorisation in the EU
- Managing product labelling
- Case study two
- Abridged applications and Generics
- Product life cycle; post approval
- Patents and SPCs
- Parallel trade
- Post-authorisation obligations; pharmacovigilance, variations and renewals
- Pharmacovigilance
- Licence variations
- Extensions
- Case study three
- Renewals
- Sunset clause
- Phase IV clinical studies
- Classification change
- Generic development
- Strategic considerations (summary)
- Criteria for successful products
- Current status of EU proposed legislation changes and implementation timelines
Speaker
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 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.
For more information about this training visit https://www.researchandmarkets.com/r/ymkeu4
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