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overview
Key Learning Objectives
- Gain a complete overview of the EMA and the various types of MAAs
- Understand the regulatory affairs throughout the product development including R&D, manufacturing, clinical trials and PV
- Learn the procedures for gaining clinical trial approval and appreciate the importance of GCP
- Gain an insight into the new CT Regulation and to prepare for future changes
- Discover what goes into a drug dossier application to ensure speedy approvals
- Examine the CTD with a detailed focus on the CMC/quality module, non-clinical study reports module and clinical study reports module
- Appreciate the difference between pharmaceutical and biopharmaceutical products and compare the key regulatory differences
- Understand the requirements of packaging and labelling pharmaceutical products in the EU
- Learn how to file for variations in your product post approval for efficient life cycle management
- Gain a solid grounding in pharmacovigilance and understand the importance of building a PV strategy to maintain patient safety
About the Course
This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. Over 5 weeks and 8 modules you will gain a clear understanding of the EU regulatory structure and have a solid grasp of the submission process and the standards required by the regulators.
This course will give you a practical insight into the European regulatory environment throughout the whole product life cycle including: non-clinical and clinical studies, the various submission procedures, labelling and packaging, post-MAA obligations and activities and more.
Who Will Benefit
Those new to Regulatory Affairs or wishing to update their knowledge on European regulatory affairs
- Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
- Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
- Regulatory Affairs, Registration and Documentation Assistants/Officers/Managers
- Those in other areas of the pharmaceutical industry such as development or manufacturing
- Project Management who would find knowledge of the regulatory environment useful
Testimonials
“The online sessions allowed me flexibility to fit training into my busy work schedule.”
Regulatory Publisher, Novo Nordisk
Benefits of Learning Online
Informa Corporate Learning’s online courses are new digital, interactive and engaging educational experience designed to maximise learning for professionals with busy schedules and/or small training budgets.
Our online courses are perfect opportunity for busy professionals as they require just 2 hours per week of your time and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis, so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Agenda
Each module contains approximately 1 hour of content
Module 1:
Overview of EU regulatory framework
- Regulatory bodies and competent authorities
- Legislative system
- The 4 main status for your products: medicine, medical device, food supplement and cosmetics
- Medicines: the EU pharmaceutical law and where to find it
Module 2:
Product development: non-clinical studies
- The Target Product Profile
- Non-clinical development
- Toxicology
- Pharmacokinetics and toxicokinetics
- Environmental risk assessment
Module 3:
Product development: clinical studies
- The current Clinical Trial Directive
- The new Clinical Trial Regulation
- Regulatory and ethical approval guidance
- Good Clinical Practices (GCP)
- Special cases for children
Module 4:
Marketing Authorisation Application 1/3: the regulatory procedures
- Centralised procedure
- Decentralised procedure
- Mutual Recognition procedure
- Specific procedures: orphan drugs, paediatric medicines, advanced therapies, herbal medicinal products
- Scientific advice
Module 5:
Marketing Authorisation Application 2/3: the registration dossier
- GxP and MA dossier
- Overview of the Common Technical Document (CTD)
- Requirements for the different Modules:
- Module 1 – Administrative data
- Module 2 – Summaries
- Module 3 – CMC/quality
- Module 4 – Nonclinical studies
- Module 5 – Clinical studies
- Electronic submissions: NeeS and eCTD
Module 6
Marketing Authorisation Application 3/3: labelling and packaging requirements
- Overview of the directives and guidelines
- Assess SmPC requirements
- Labelling requirements
- Examine Patient Information Leaflets (PILs) in Europe
- Overview of readability guidelines
Module 7
Post-MAA: filing variations and renewals
- Introduction to filing variations
- Variations requirements and procedures
- Compare the different types of variations: Type IA, IB and II
- Variations vs extensions
- Renewal legislation and procedures
Module 8
Post-MAA: Pharmacovigilance obligations
- Good Pharmacovigilance Practices
- Pharmacovigilance system
- Periodic safety update reports (PSURs)
- Risk Management Plan and Post-authorisation safety studies (PASS)
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.