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Nov.
2017

GMP for Clinical Trials Manufacture and Supply

Netherlands, Amsterdam

6 nov. 2017 - 9 nov. 2017

Entrée : 2 670,00 £ (HTVA)

Déjeuner: inclus
Early bird and multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Ajouter

Course Overview :

This highly interactive 4 day training course will teach you all you need to know about international GMP regulations and requirements for the manufacture, control, storage and distribution of medicines to be used in clinical trials. Our tutors, both of whom are former regulatory agency inspectors, will help you to interpret the legislation and guidance into simple pragmatic ways of working that meet the needs of the regulators. They will also help to answer any specific questions you may have regarding your products and studies.


About This Course :

Keeping up with the changing legislation in the area of clinical trials provides challenges for all those working with Investigational Medicinal Products. Our highly interactive 4-day course is taught by ex-MHRA Inspectors; all experts in the field of clinical manufacturing and regulatory requirements. This provides an excellent opportunity for gaining invaluable knowledge about the ever-changing world of clinical supplies.

Practical exercises in this course (such as the “Tic Tac” double dummy packaging exercise) help to reinforce key learning points. Come and join us in Amsterdam to gain a thorough understanding of GMP requirements for clinical supplies, or just to keep up-to-date with what’s changing in this area.

This course is also Royal Society of Chemistry approved as suitable for their members’ Continuing Professional Development.


Key Learning Objectives :

  • Understand the legislation and guidance around clinical trials and what is changing
  • Understand the interpretation of GMPs suitable for clinical trials
  • Understand the phases in clinical trials and how requirements change
  • Auditing and control of clinical trial operations
  • Clinical batch releases


Registration link :

  • NSF Online registration : Link

NSF contact :

Note : 

  • All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Course Outline:

Clinical Trials

  • What are they?
  • Phases of clinical development

EU Legislation Impacting Clinical Supplies

  • The new CT Regulation 536/2014
  • The current CT Directive 2001/20/EC
  • The GMP Directive 2003/94 and the proposed changes

Annex 13 Requirements for IMPs

  • EU and FDA expectations compared – What’s Changing?

Product Development and Design

  • Product and process understanding
  • Risk-based thinking

Supply Chain Management

  • Controls on starting materials
  • Controls on contractors
  • Importation requirements
  • Sourcing comparators
  • Release procedures
  • Quality/Technical Agreements

GMP Requirements for APIs

  • Section 19 of EudraLex Vol 4 Part 2

GMP Considerations for Clinical Manufacture

  • Minimizing cross-contamination
  • The application of ICH Q10
  • The importance of risk management
  • The importance of the change management system
  • Protecting the patient and the trial data

Packaging and Labeling

  • Controls of packaging components
  • Printing and label controls
  • Blinding issues
  • Practical considerations

QC Requirements

  • Stability testing and expiry dating
  • How much testing is required?

Validation Issues

  • How much and how soon?
  • Process validation
  • Analytical method validation
  • Cleaning validation or verification

Documentation

  • What is in an IMPD?
  • ​The importance of a Product Specification File

Data Integrity in Clinical Trial Manufacture

  • What is it and why is it important?

Release Procedures and the Role of the QP

  • QP responsibilities
  • Two-stage release process
  • Use of IWRS

The GMP/GCP Interface

  • Issues that fall in the interface
  • Audit findings in this area

Shipment to Clinical Sites

  • Cold chain supplies
  • Transportation

Typical Regulatory Inspection Findings

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    Darren Jones

    Consultant

    NSF Health Sciences Pharma Biotech

  • No picture

    Richard Funnell

    Consultant

    NSF Health Sciences Pharma Biotech

Suivant

Résumé

Darren Jones has 25 years of experience in pharmaceutical auditing, consulting and regulatory inspection support and preparation. Prior to joining NSF, Mr. Jones worked at MHRA where he spent four years as a GMP inspector. He inspected many sites of varied dosage forms worldwide and developed considerable experience of complex aseptic manufacture and terminal sterilization for both commercial and clinical trial applications.

Earlier in his career, Mr. Jones spent 18 years in a number of roles at AstraZeneca, including production outsourcing, selecting and managing contract manufacturing sites primarily engaged in sterile manufacture.

Mr. Jones has provided QA support to an API facility which included laboratory-scale production for parenteral products, traditional manual plant and modern computer-controlled facilities. He has also provided QA support to tablet processing and packaging activities.

Mr. Jones’ areas of expertise include :

  • GMP auditing of facilities and processes
  • Sterile manufacture
  • Clinical trial manufacture
  • Supply chain excellence
  • Microbiological QC

Richard Funnell has 30 years’ experience in the pharmaceutical industry in both regulatory and industrial roles. He worked within the MHRA GMP inspectorate from 2003 until 2014, including seven years as a senior inspector when he was the lead for investigational medicinal products (IMP) Good Manufacturing Practices (GMPs).

While at the MHRA, he inspected over 300 different sites within the UK and overseas. He also presented at numerous conferences and symposia on a wide variety of GMP-related topics.

Before joining the MHRA, Mr. Funnell  spent 17 years in industry in a number of roles in the production and quality assurance of tablets, oral liquids and sterile products.

He became QP eligible in 2002 after attending the NSF series of courses.

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