PharmaQMtraining.eu


Course Outline

A 2-day non-residential course on Regulatory Affairs with emphasis on
Background, Content and Detail of Module 3 of the Common Technical Document (CTD), the ‘Quality Module’

Aim
To ensure your understanding and correct interpretation of the regulatory requirements concerning Chemistry, Pharmacy and GMP/GDP Compliance issues for Drug Substances and Drug Products, to help you produce a licensing dossier without common faults

TIMETABLE

2 July
Registration
09.15h
Day 1 Start
09.30h
Finish
16.45h
3 July
Day 2 Start
09.00h
Finish
16.45h
AGENDA
Although the following is not the running order, the course content includes:
INTRODUCTION AND WELCOME

INTRODUCTION TO THE INTERNATIONAL CONFERENCE ON HARMONISATION (ICH)

  • ICH, its guidelines and the Common Technical Document (CTD)
  • CTD Module 2.3 and Module 3

INTRODUCTION TO THE EUROPEAN REGULATORY SYSTEM:

  • EU and Council of Europe operations and regulatory tasks
  • Pharmaceutical legislation
  • EU guidelines
  • The European Pharmacopoeia
INTRODUCTION TO THE ACTIVITIES AND INFLUENCE OF THE EUROPEAN PHARMACOPOEIA
THE PURPOSE, FORMAT AND CONTENT OF THE QUALITY OVERALL SUMMARY, CTD MODULE 2.3

STARTING TO BUILD CTD MODULE 3

  • Understanding how the legislation, official guidelines, European Pharmacopoeia and other Council of Europe publications shape the required content of CTD Module 3

UNDERSTANDING DRUG SUBSTANCE ISSUES AND CONTRIBUTIONS TO CTD MODULE 3

  • Starting and other materials in a chemical synthesis
  • Chemistry development issues: characterisation, analytical validation, specifications and their justification
  • Data provision options for manufacturing and control including Master Files and Certificates of Suitability
  • ‘Conventional’ organic impurities
  • Other impurities: residual solvents, residues of metal catalysts and reagents, inorganic impurities, genotoxic impurities, enantiomeric impurities
  • Stability
  • Specifications
  • Common deficiences
  • Sourcing of drug substances, GMP, vendor verification, pedigree, QP certification

THE FALSIFIED MEDICINES DIRECTIVE - the new API importation rules from 2 July 2013

  • Objectives and Responsibilities
  • Status of implementation - UK and across Europe
  • Likely Impacts on
    • Active substances
    • Medicinal products - EU and non EU manufacturers
    • API producers
    • .... and more
  • The next major issues of track & trace and tamper evidence
FMD QUESTIONS & ANSWERS SESSION

UNDERSTANDING DRUG PRODUCT (DOSAGE FORM) ISSUES AND CONTRIBUTIONS TO CTD MODULE 3

  • Starting and other materials in drug formulation
  • Pharmaceutical development: composition, functions, optimisation, performance, bioequivalence
  • Manufacturing process         
  • In-process and end-product control including specifications and their justification
  • Stability
  • Numerous examples
  • Common deficiencies
Previous page

EXCEPTIONAL VALUE: £1095.00 + VAT

High-quality, carefully-structured training, daytime in-course refreshments including a sandwich lunch, a certificate of attendance and a substantial delegate's manual to reinforce the learning experience

MORE ABOUT THE BACKGROUND TO THIS COURSE
AND WHO SHOULD ATTEND

This Course will be an up-to-date comprehensive and group interactive course that builds from first principles and explores numerous pharmaceutical topics that have to be addressed in supporting documentation for Marketing Authorisation Applications (MAAs). 

The course will include latest news about how to be GMP compliant and more .... in accordance with the Falsified Medicines Directive in respect of the supply chain for drug substances and drug products.

The course has been well developed over many years and has been highly regarded by delegates of varied experience in regulatory affairs and associated departments. Past delegates have been and future ones are expected to be from within the pharmaceutical and chemical industries (chemical development, analytical, formulation and pharmaceutical development, manufacturing, regulatory/registration departments, auditors) and the Competent Authorities (assessors, inspectors, scientific/medical writers).

The course is structured to be suitable for delegates of various abilities and experience. Whether you are relatively new to regulatory affairs/registration work or more knowledgeable, even in Quality subjects, and perhaps looking for up-to-date training in Chemistry, Pharmacy and GMP/GDP Compliance subjects prone to change, you will gain valuable insight from the programme.

COURSE LEADERS

The trainers will be Professor Derek Calam, Paul Fleming and Dr Mike Robertson who between them have many years of experience within UK, European and WHO institutions and have reviewed numerous MAAs.

Book here

Please sign up for future announcements

Previous page

Links | Privacy Policy | Terms & Conditions | Contact