Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance?

Why Should You Attend:

Are you up to date with the new European clinical trial regulation requirements?

On 2 April 2014, the European Parliament approved the new European Union Clinical Trials Regulation and on 27 May 2014, the EU Clinical Trials Regulation (No 536/2014) was published in the Official Journal of the EU (OJEU). The new regulation will have a significant impact on how to conduct multinational clinical trials in Europe because it provides for:

• An authorisation procedure for clinical trials which will allow for a fast and thorough assessment of the application and which will ensure one single assessment outcome
• Simplified reporting procedures
• More transparency on whether recruitment for participating in a clinical trial is still ongoing and on the results of the clinical trial

This course will take you through the most important new regulatory requirements for clinical trial regulation in Europe, and also those that have an impact on trials internationally. The course will highlight changes in existing requirements and how these are likely to impact 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 to be prepared for these important changes. With this course, you can eliminate the confusion and ensure compliance with EU requirements for clinical trials.

Areas Covered in the Webinar:

• Important update on the new Clinical Trial Regulation in the European Union and its international impact
• 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 outside such as in the US or other emerging markets
• Non-EU sponsors – what will be the impact to ensure an effective supervision of a clinical trial
• Considerations for insurance coverage of the medical practitioner, the institution, or product liability insurance
• Ensure you comply with the proposed changes for pharmacovigilance and adverse event reporting
• Sponsors will report unexpected serious adverse events directly 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 and 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 personnel
• Clinical research associates
• Clinical research archiving and document management personnel
• Quality assurance managers and auditors
• CROs using laboratories to analyse clinical trial samples
• Project management
• Sponsors and non-commercial sponsors
• Consultants
• Laboratories analysing samples from clinical trials
• Regulatory affairs personnel
• Legal and regulatory authorities

Instructor Profile:

Dr. Laura Brown, PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA.

Dr. Brown has 20 years’ experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy. She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.

Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “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 in training courses on QA and GXP issues. Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013).

She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.

Topic Background:

The new Clinical Trials Regulation introduces an overhaul of the existing regulation for clinical trials for medicinal products in the EU. The regulation will be directly binding in all EU member states without the need for any national implementing legislation.

The European Commission is going to entirely replace the Clinical Trial Directive in light of widespread criticism from patients, researchers and industry alike. Of particular concern was the lack of harmonization between countries and the high cost of complying with the directive. “This has contributed to a significant decline of clinical trials in the EU,” wrote the commission. “Between 2007 and 2011 the number of clinical trials conducted in the EU fell by 25%. This new single regulatory proposed framework will allow the pharmaceutical industry to avoid the current ‘patchwork’ of national frameworks.”

The new legislation will immediately affect an enormous amount of clinical research and it will be critically important to understand the new requirements.

The EU health commissioner said the revised rules "will ensure that the EU remains an attractive location for clinical research (2013). However, there are significant concerns remaining about how the legislation will impact on audit and inspection.”

This webinar will help sponsors, CROs and study sites running clinical trials in the EU and internationally understand the important new compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).

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