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Pharmaceutical Regulatory Affairs in the EU and US




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Reference No: T1708001-PTI

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Key points about this Training Event

  • Discover the origins and purposes of pharmaceutical regulation, and the principal regulatory bodies
  • Know how to ensure your pre-clinical and clinical studies comply with both key EU and US regulations, including GLP, GCP, the EU Clinical Trials Directive and FDA requirements
  • Learn the fundamental procedures, issues and initiatives (including the FDA Critical Path) that will have an impact on your regulatory strategy
  • Gain awareness of other procedures so you can manage the approval process for a range of product types (including biosimilars, generics and variations)
  • Find the approach to gaining marketing authorisation that works for your markets – and make sure you meet the required safety standards
Event Description

Course Overview

This 9-module self-study course has been specifically designed for new entrants to pharmaceutical regulatory affairs wanting a complete overview of the issues and systems affecting the approval of their products..

Work through the course at your own pace online, test your knowledge with end of module quizzes and receive a certificate once you've passed the final course quiz. This course is available for individual registrations or can be supplied to a department as a licence for a year.

Who Should Register?

This course is useful for anyone who works directly or indirectly with regulatory affairs.

Regulatory Affairs Executives
Regulatory Affairs Managers

Course Agenda

Module 1 - Introduction to EU Regulatory Affairs in the EU

  • Origins and purposes of regulation
  • Basic elements and approaches in regulation
  • EU institutions and legislation
  • Approaches to EU registration
  • Centralised
  • Mutual Recognition
  • Decentralised
  • National
  • Risk Management
  • Other EU Legislation 
  • Role of the regulatory affairs professional

Module 2 - Introduction to Regulatory Affairs in the US and other Global markets

  • US FDA overview
  • US Administrative procedure
  • FDA Good Guidance Practices (GGP)
  • Appeals procedure
  • Regulatory bodies in other countries
  • US Medicare/Medicaid
  • UD Drug Enforcement Administration
  • US Federal Trade Commission

Module 3 - Regulatory considerations throughout the product life cycle

  • Introduction to ICH
  • Preclinical studies
  • Good Laboratory Practices (GLPs)
  • Clinical Trials/Good Clinical Practice
  • EU Clinical Trials Directive
  • EU privacy legislation
  • FDA clinical trials regulation

Module 4 - Understanding the Common Technical Document (CTD)

  • ICH Common Technical Document
  • EU and FDA similarities and differences
  • Quality (Chemistry/Manufacturing Controls)
  • Safety
  • Efficacy

Module 5 - Introduction to regulatory affairs for generics with a focus on intellectual property (IP) law

  • Abridged applications for generics
  • Introduction to Intellectual Property Law
  • Bolar issue
  • Supplementary Protection Certificates
  • US patent term restoration
  • EU/US regulatory exclusivity periods
  • Orphan drugs regulation
  • EU/US parallel trade issues
  • Programmes for developing countries

Module 6 - Regulatory overview of OTCs, Herbal Medicines and Homeopathics

  • Homeopathics
  • Herbals
  • Radiopharmaceuticals
  • Influenza
  • Vaccines
  • Narcotics/controlled drugs

Module 7 - Introduction to regulatory affairs for biologics, novel therapies and other special categories

  • Biologicals and Biosimilars
  • Blood and blood products
  • Cells, tissues, organs, gene therapy, cloning
  • Renewals
  • Variations
  • Product Master Files

Module 8 - Regulatory overview of labelling, pharmacovigilance, counterfeit products

  • Labelling overview, EU/US
  • Pharmacovigilance in the EU
  • Pharmacovigilance in the US
  • GMPs
  • Inspections
  • Enforcement in the US
  • Enforcement in the EU

Module 9 - Advertising and marketing practices

  • Role of pharmaceutical industry in both promotion and medical education
  • EU Community Code on Medicinal Products
  • EFPIA and ABPI Codes and national codes
  • FDA regulation
  • Leading US and EU cases
  • Compliance strategies


£999.00 + VAT @ 20% = £1,198.80

Course Leader

Nicholas Wells

Nicholas has been the managing director of Independent Pharma Consultants in the UK since 2005 and has been working in the field of regulatory affairs since 1998. He has extensive global regulatory experience gained through a successful career with companies including Abbott, Novartis and Pfizer, where he has held a number of senior positions. Clients turn to Nicholas for assistance not only in meeting regulatory requirements, but also in designing strategies for developing and marketing products in the EU and US. He holds a degree in Applied Biology and is a member of TOPRA.

See What Others Are Saying About This Course On Our Forum

Forum Link - Pharmaceutical Regulatory Affairs in the EU and US


Additional terms and conditions apply upon application.

Applicant Requirements
  • Regulatory Affairs Executives
  • Regulatory Affairs Managers
  • Anyone who works directly or indirectly with Regulatory Affairs
Reference No: T1708001-PTI
PTI is an internationally renowned training company specialising in public, on-site and distance learning training initiatives. Our highly experienced faculty of trainers provide the very latest information on pharmaceutical compliance, operational and strategic issues.



Nicholas Wells

Nicholas has been the managing director of Independent Pharma Consultants in the UK since 2005 and has been working in the field of regulatory affairs since 1998.

Email Nicholas Wells

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