Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance

Why Should You Attend:

Are up to date with the new proposed European clinical trial regulation requirements?
This course will take you through the most important, newly proposed, regulatory requirements for clinical trial regulations in Europe, and their impact on clinical trials internationally.

Attending this webinar will help ensure that you are familiar with the proposed new regulation for running clinical trials and are prepared to be able to implement the new requirements efficiently. The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials for Pharmaceutical companies, CROs, Vendors and Study Sites.

Regulatory inspectors will expect those involved in clinical trials to be aware of the new regulation for controlling clinical trials. This essential course will also be ideal for disseminating the information to your staff and colleagues so that they can be prepared for these important changes.

Areas Covered in the Webinar:

• Important update on the proposed Clinical Trial Regulation in the European Union and the impact it will have internationally
• Decipher the content of the new proposed Clinical Trial Regulations in Europe
• How clinical trials will be authorized in the future
• The option of “co-sponsorship
• The legislation will allow clinical trials to commence in “emergency situations” without the consent of an individual
• EU regulators will have the authority to perform inspections of all clinical trials registered in the EU whether they are conducted within the EU or in outside such as in the US or emerging markets
• Non-EU Sponsors – what will the impact me to ensure an effective supervision of a clinical trial?
• Considerations for insurance coverage of the medical practitioner, the institution, or product liability insurance provides sufficient coverage
• Ensure you Comply with the proposed changes for Pharmacovigilance & Adverse Event Reporting
• Sponsors will report unexpected serious adverse events directly reported to the European EudraVigilance database
• What you need to know about Regulatory Inspections for the new regulatory requirement

Who Will Benefit:

This webinar will provide critical assistance to FDA and EMA regulated companies including professionals in pharmaceutical, biotechnology, CRO, SMO, vendor companies, or study sites including investigator initiated studies. It will also be of interest to those departments who liaise / support clinical trial personnel such as:

• Clinical Development managers and personnel
• Clinical operations
• Clinical research associates
• Clinical Research archiving and document management personnel
• Quality assurance managers and auditors
• Clinical Development managers and personnel
• CROs using laboratories to analyze clinical trial samples
• Project Management
• Sponsors and non-commercial sponsors
• Consultants
• Laboratories analyzing samples from clinical trials
• Regulatory affairs
• Clinical trial supply
• Pharmacovigilance
• Document management
• Legal, regulatory authorities
• and all other professionals who want to know more about regulations and guidelines covering clinical trials.

Instructor Profile:

Dr Laura Brown, PhD, MBA, Diploma Clinical Sciences, is an independent QA and Training Consultant in the Pharmaceutical Industry as Managing Director LB Training and Development Ltd. , Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff, and Course Director MSC Regulatory Affairs, TOPRA .

Laura has almost 20 years’ experience of running clinical trials and clinical quality assurance in the pharmaceutical industry, including auditing clinical trials internationally.

Dr 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.

Dr Brown has published a practical guide to the clinical trial directive, 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 GXP issues.

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