A Beginners Guide to EU Regulatory Affairs - Online Academy (Four 2-Hour Sessions Over 4 Weeks)

  • ID: 4267689
  • Training
  • Region: Global
  • Pharmaceutical Training International
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A practical insight into the European regulatory environment throughout the whole product life cycle

This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. Over 4 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: clinical trials requirements, the structure of the registration dossier, biotech regulations, labelling and PV obligations.

  • 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

Who should register?

  • 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

This online academy course can be accessed from Monday 6th November. Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

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Module 1: Introduction and EU Overview

  • Role of the regulatory affairs professional
  • Overview of the European Medicines Agency (EMA)
  • Different types of MAAs:
  • Centralised procedure
  • Decentralised procedure
  • Mutual recognition procedure
  • Competent authorities
  • Timelines

Module 2: Regulatory Affairs Throughout Product Development

  • R&D & Good Laboratory Practice (GLP)
  • Pre-clinical studies
  • Manufacturing & Good Manufacturing Practice (GMP)
  • Clinical trials & GCP
  • Overview of other GxP requirements throughout the product lifecycle

Module 3: Clinical Trial Regulations and Applications

  • Overview of the Clinical Trial Directive
  • Examine the new Clinical Trial Regulation: comparison with the current Directive
  • Discuss Good Clinical Practice (GCP)
  • Regulatory and ethical approval guidance
  • Special case for children

Module 4: Compiling a Drug Registration Dossier: What Information is Needed and How to Present it

  • Overview of the Common Technical Document (CTD)
  • Examine administrative data required to be presented in Module 1
  • Understand the key importance of the Summary of Product Characteristics (SmPCs)
  • Assessing the 5 modules in the CTD with focus on
    • Module 3 – CMC/quality
    • Module 4 – nonclinical study reports
    • Module 5 – clinical study reports
  • Electronic submissions: NeeS and eCTD

Module 5: Regulatory Affairs for Biotech Products

  • Differences between small molecules and biotech
  • Examples of biologics: Cells, tissues, organs, gene therapy, cloning
  • Review the major differences in regulations
  • Manufacturing/ CMC
  • Data requirements
  • Dossier application

Module 6: Labelling and Packaging Requirements

  • Overview of the directives and guidelines surrounding labelling
  • Examine Patient Information Leaflets (PILs) in Europe
  • Assess SmPC requirements
  • Overview of readability guidelines

Module 7: Filing Variations & 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: Pharmacovigilance (PV) Obligations

  • Role and function of PV
  • Continuous PV requirements
  • Examine safety reports
  • Discuss risk management plans
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Salma Michor, PhD, RAC is the founder of Michor Consulting providing services to the pharmaceutical and medical device sectors, specializing in regulatory affairs, regulatory compliance, quality assurance, risk management and interim management. Michor Consulting is an established and licensed entity, and can act as your European Authorised Representative for CE marked medical devices. Dr.Michor serves as an independent expert for the European Commission since 2004, evaluating and reviewing industrial research projects for Small and Medium sized Enterprises(SMEs) and the Marie Curie Fellowships programme for the 6th and 7th Framework programmes.

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