This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.
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:
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
Course Provider
Laura Brown,
