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The EU Pharmaceutical Dossier ~ CTD Modules 2.3 and 3

In Basel ()

£ 1,280 VAT exempt

Description

  • Typology

    Course

  • Duration

    2 Days

Description

Learn about the key components of the EU licensing systems for substances for pharmaceutical use and for finished medicinal products. Delegates will learn about sources of official information and expert guidelines, and will find out how to prepare the 'Quality' parts of the CTD (in Modules 1.3, 2.3 and 3). Information will also be given on common deficiencies in the pharmaceutical dossier.
Suitable for: The course will be of particular interest to all those who need to learn about the chemical and pharmaceutical aspects of successful marketing authorisation applications including: Scientists,Technical Staff and Managers in: Regulatory Affairs/Registration Departments. Analytical Research and Development. Pharmaceutical Formulation. Product Development. Quality Assurance. Scientific and Medical Writing. Regulatory Authorities.

Important information

Documents

  • EU Pharma Dossier

Questions & Answers

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Teachers and trainers (2)

Dr Michael  Robertson

Dr Michael Robertson

European Regulatory Affairs Consultant Pharmaceutical Quality Matters,

Professor Derek  Calam, OBE

Professor Derek Calam, OBE

Commission’s Expert Advisory Group on Chemistry, Pharmacy and Standard

Course programme

About this Course

No VAT is applicable for this Event

The conference will provide a wide-ranging, up-to-date coverage of the pharmaceutical issues that underpin a successful marketing authorisation application. In a carefully-structured programme, delegates will learn about the key components of the EU licensing systems for substances for pharmaceutical use (that is Active Ingredients and Excipients) and for finished medicinal products. Delegates will learn about sources of official information and expert guidelines and will find out how to prepare the 'Quality' parts of the CTD (in Modules 1.3, 2.3 and 3). Information will also be given on common deficiencies in the pharmaceutical dossier. It is anticipated that the course will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas.

The speakers have had many years' experience working in or for the UK regulatory authorities and also for various other bodies with multi-national regulatory activities.

There will be ample opportunity for question and answer sessions throughout the two days of the course, further to enhance the delegates' understanding of pharmaceutical issues of individual concern.

WHO SHOULD ATTEND

The course will be of particular interest to all those who need to learn about the chemical and pharmaceutical aspects of successful marketing authorisation applications including:

Scientists, Technical Staff and Managers in:

  • Regulatory Affairs/Registration Departments
  • Analytical Research and Developments
  • Pharmaceutical Formulation
  • Product Development
  • Quality Assurance
  • Scientific and Medical Writing
  • Regulatory Authorities
  • Producers/Suppliers of Active Ingredients or Excipients

SPEAKERS:

Dr Michael Robertson - European Regulatory Affairs Consultant at the pharmaceutical regulatory consultancy Pharmaceutical Quality Matters, UK
Professor Derek Calam, OBE -Member of the Commission on Human Medicines and Chairman of that Commission’s Expert Advisory Group on Chemistry, Pharmacy and Standards, UK

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The EU Pharmaceutical Dossier ~ CTD Modules 2.3 and 3

£ 1,280 VAT exempt