Global Webinar: Regulatory & EMEA Inspections in Europe and Progress Update

This webinar is in its third successful year. Take the opportunity to listen and direct questions to an experienced QA Expert who has been involved in numerous types of inspections worldwide.

Over the past few years the number of Regulatory & EMEA (European Medicines Agency) inspections has increased. This is due to GCP Inspections becoming mandatory since the implementation of the EU Directives. The GCP Inspectors’ Working Group at the EMEA have implemented a guidance document which covers the procedures for the coordination, preparation, conduct and reporting of GCP inspections carried out in the context of the Centralised Procedure. The group meets regularly with representatives of the GCP inspectorates of the European Economic Area to help coordinate the EU inspections and to assist with harmonisation and the development of procedures, for EU GCP inspections. 

This webinar covers the types of inspections that European inspectors conduct, what they expect in the course of the inspections and why. This will help you appreciate how well prepared you are and the further actions that you can take now to ensure that you are ready for your inspection. The main focus will be on GCP inspections at the investigator’s site and sponsor’s offices, but an overview of GMP and pharmacovigilance inspections will also be given.

Whether you are located in the European Union or not, as long as you run or take part in studies involving EU sites or studies that will be submitted within a Marketing Authorization application in Europe, this webinar is of value to you. Inspectors can – and do - ask questions to any member of the clinical research team including junior staff members. This webinar will be important and helpful to the whole research team.

After a formal presentation Mr. Seymour will take questions from the audience live.

Session Objectives

Upon completion of this session, participants should be familiar with:

• The European Medicines Agency (EMEA) Inspections
• The National Competent Authority Inspections
• Progress update on the EMEA and CA inspections
• GCP Inspector’s Working Group and the coordination of EU GCP Inspections
• The different types of inspections that may occur
• What an inspection involves and what to expect
• When and where to expect inspections
• What is the remit of inspectors
• What inspectors are really looking for and why
• The approach that inspectors take
• How to best prepare for inspections, before one is announced
• How to coordinate the inspection when it comes
• Where clinical researchers typically fall short of the inspectors’ expectations and why

Target Audience

This webinar will be of major interest to:

• Project directors, project managers and CRAs in the pharmaceutical industry and CROs especially those based outside the UK, conducting studies with investigator sites in any of the 27 European Union (EU) countries, whether the study is being conducted before or after submission for a Marketing Authorization and irrespective of the mode of Marketing Authorization planned.
• Investigators and research nurses/coordinators in the EU taking part in any study
• Investigators and research nurses/coordinators outside the EU taking part in studies that may be submitted in a Marketing Authorization Application to European Competent Authorities

Q&A

If you'd like the speaker to address specific questions during the session send your questions by Monday, June 9, to siobhan@acrpnet.org. There are 30 minutes provided at the end of the webinar to ask questions in real time.

Queries

For any queries or if you are not sure about the time of this webinar in your time zone, please email euroffice@acrpnet.org

Presenter

Bruce Seymour-Taylor, Director, Global Clinical Quality Assurance – Europe and Asia Pacific, Johnson & Johnson Pharmaceutical Research & Development

Bruce has more than 27 years experience within the pharmaceutical industry.  He has held a number of positions in his career initially in clinical research with Warner Lambert as a CRA with progression into management positions within this discipline. With the advent of clinical quality assurance in Europe in the mid 80’s, Bruce was asked to set up a CQA group for Warner Lambert. Bruce then moved into consultancy, specialising in compliance training and audit. Later he moved back into the industry and set up a Clinical QA group for the French pharmaceutical company, Lipha, in Lyon, France. Four years later Bruce joined Johnson & Johnson in Zurich, Switzerland to perform another set up job. He is now based in the UK with J&J.

Bruce has a great deal of experience in dealing with regulatory compliance issues in the clinical field on a global basis.  He holds an Honours Degree in Applied Biological Sciences.

Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.