Eliminate the Confusion –Annex 13 GMP guide

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Why Should You Attend:

The European Commission has passed and published the final version of Annex 13 ("Investigational Medicinal Products") to the EC GMP Guide. The new Annex comes into force in July 2010. It calls for special attention in areas to GMP conformity for investigational medicinal product by personnel working on clinical trials. Compliance can be achieved especially thorough training, some possible changes in processes and revision of some GMP standard operating procedures. These enhanced requirements reflected in the revision of Annex 13 are part of the strict regulations now in force in the European Community.

The session will review the guideline to cover the key areas of compliance including: The role of the "Qualified Person", Packaging, labeling, reconciliations that should take place for each product and each production stage, and Comparator product requirements etc.

Areas Covered in the Seminar:

• Review the role of the "Qualified Person" who must have access to the Product Specification File as the basis for assessment of the suitability for release and certification of a particular batch.
• Packaging instructions requires expressly with a view to the complicated procedures in the manufacture of investigational medicinal products.
• The requirement for reconciliation at the end of the packaging and labelling processes.
• Packaging materials requires special quality control checks for a homogeneous appearance of the packs in order to prevent unintentional unblinding due to a visible difference between the placebo and the active medication packs.
• Manufacturing operations that the production parameters and the corresponding in-process controls must be deduced from the knowledge actually available at the time.
• An appropriate process of blinding the test preparation, comparator product and placebo must be completely identifiable.
• The requirements for the randomisation procedure are also more strictly formulated: in addition, safety aspects and the procedure for breaking the code must be described in the corresponding procedures.
• The section on the risks of product mix up in the case of simultaneous packaging of different preparations.
• Labelling is specifically detailed in the draft e.g. name, address and telephone number of the sponsor, contract research organisation or the principal contact for the clinical trial.

Who Will Benefit:

• Clinical Research Professionals
• Clinical Research Project Managers
• Technical Directors / VP's
• Operations / Production Managers
• Quality Assurance Managers
• SOP mangers and co-ordinators

Instructor Profile:
Dr Laura Brown, PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 17 year’s experience of running clinical trials and clinical quality assurance in the pharmaceutical industry.

Laura Brown has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.

Laura is author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices” (2007). She is author of SCRIP’s latest GCP guide and a “Practical Guide to the Clinical Trial Directive. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and on training courses on QA and GCP issues.

Laura developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (A regulatory commercial e-learning training organization) in 2008.

Laura runs many training courses both on public courses and in-company on topics including: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP , the clinical trial directive, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection.