GMP meets Regulatory Affairs

GMP meets Regulatory Affairs

Heidelberg, Germany

Course No 15721


Costs

Non-ECA Members: EUR 1790,--
ECA Members: EUR 1590,--
EU GMP Inspectorates: EUR 895,--
APIC Members (does not include ECA membership): EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Marieke van Dalen, Aspen Oss B.V., The Netherlands

Dr Josef Hofer, EXDRA GmbH, Germany

Dr Usfeya A Muazzam, Bonn, Germany

Dr Rainer Gnibl, EU-GMP Inspector, Bavarian Government

Objectives

During this course you will get to know the relevant aspects of applying for and maintaining a marketing authorisation in the ICH countries. You will learn what you need to know from a GMP perspective about

  • the basic requirements for drug approval in Europe, the US and Japan
  • the structure of the marketing authorisation dossier according to the CTD
  • the input from the GMP regulated departments
  • drug approval procedures in the EU and US
  • documents to be provided and timelines to be observed
  • how to handle changes and variations in the EU, the US and Japan

Background

For getting a drug approved it is required to demonstrate its quality efficiency and safety. For that purpose the format of the Common Technical Document (CTD) which is mandatory in Europe since more than 10 years now has to be used. It is also used to apply for a marketing authorisation in the US and Japan.

Therefore a good understanding of the CTD structure is inevitable and a basic requirement for all persons from GMP regulated departments involved in providing and compiling documents for a marketing authorisation application.

For the maintenance of a marketing authorisation it is very important to know how to handle all the changes and variations occurring during the life cycle of a medicinal product.

The rules for handling variations in Europe are laid down in the variations regulation (EC) No. 1234/2008 – being applicable as well for national marketing authorisations from August 3rd 2013 – and supporting guidelines.

For handling changes in the US rules are provided in different guidances for industry and for approval of changes in Japan there are specific procedures in place to be followed. Maintaining marketing authorisations in a global scenario is a challenge and requires strategic planning and a good knowledge of the different regulations and timelines.

Efficient and smooth communication between GMP and Regulatory Affairs is a key factor of success.

Target Group

This education course is designed for all persons involved in the compilation of pharmaceutical dossiers for global marketing authorisations in the EU and USA. Furthermore the course will be of interest to personnel from Regulatory Affairs, Quality Assurance, Quality Control and Production and Project Management.

Programme

Getting Drugs Approved - What you need to know from a GMP perspective -


What is a regulatory dossier?
  • Why do we need regulatory dossiers?
  • Why are regulatory dossiers binding?
Drug Approvals in the ICH countries: prerequisites and procedures
  • Centralized procedure
  • Decentralized procedure
  • Mutual Recognition
  • National Procedures
  • Specific Dossier Requirements for different Medicinal Products
  • Time Lines
  • Generic Applications
  • New Drug Application (NDA)
  • IND procedure and special issues
  • Abbreviated New Drug Application (ANDA) - Generics
  • Pre-approval inspections
  • Timelines and meetings with the FDA
  • Regulatory Requirements in Japan
  • GMP Regulations in Japan (J-GMP)
CTD: Module 1: Summary of product characteristics and other national requirements
  • Quality related aspects of the SmPC
  • Clinical particulars
  • Pharmacological properties
  • Pharmaceutical particulars
  • Labelling
  • Package Leaflet
  • Mock ups and Specimen
  • Quality Experts, Non Clinical and Clinical Experts
  • Bibliographical applications
  • Homeopathic Applications
  • Paediatric Application
CTD Module 3 - Quality of the Drug Product: relevant GMP documents
  • Medicinal product - documentation of quality in Module 3
  • Impurities
  • Stability data
  • Container and closure systems
  • Critical parameters
  • Optimising the submission
  • Risk based approach in industry and regulatory authority
CTD Module 3: How to document Drug Substance Quality - Certificate of Suitability (CEP) and Active Substance Master File (ASMF)
  • Documentation of drug substance quality in Module 2
  • The Quality Overall Summary (QOS)
  • CEP and ASMF procedure - how they work in principle
  • Types and format of ASMFs
  • Contents of the applicants part and the restricted part
  • How to apply for a CEP
  • Dossier Content
  • CEP assessment and CEP inspections
  • DMF procedures in US and Japan
CTD Module 4 and 5: nonclinical and clinical documentation: GMP, GCP and GLP aspects
  • Clinical study reports
  • Efficacy and safety
  • Clinical summary and clinical overview
  • Non clinical study reports
  • Toxicology
  • Pharmacokinetics
  • Safety studies - decision tree
  • Toxicity studies to qualify impurities
  • Nonclinical summary
  • Critical points
The Quality Overall Summary (CTD Module 2) - Importance and Benefits
  • Regulatory background of QOS
  • Benefits (and why you can call it "Queen of Submission")
  • Frequent deficiencies, examples
  • Optimising the submission
Regulatory Compliance aspects during authority inspections
  • Types of inspections
  • Essential PQS interfaces
  • Change control from a GMP view
  • Deviations from Marketing Authorisations
  • Inspector's planning, preparation, conduction and follow-up of GMP inspections
Technical terms of GMP inspections - EU-GMP requirements
  • EU-GMP regulations
  • Technical terms of EU-GMP guidelines
  • Basic requirements for GMP inspections

Maintaining a Marketing Authorisation - The interaction between GMP and Regulatory Affairs -


Handling changes in the ICH countries
  • Starting a change in your company
  • The variations procedure in Europe
  • General provisions of the Commission Regulation (EC) No 1234/2008
  • Supporting Guidelines
  • Best Practice Guides and Explanatory Notes
  • Classification of variations
  • Procedural handling of variations; Grouping, Worksharing
  • Handling Changes in the US: Changes to an approved NDA and ANDA
  • Types of changes
  • Change control procedure and reporting mechanisms
  • Handling changes in Japan: Change procedures and communication with the Japanese authority
  • Types of changes
  • Notification of changes

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