Compliance with EU Regulation for Clinical Trials-OnlineWebinar

Tuesday, Apr 25, 2017 at 10:00AM - 1:00PM

Event Details

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.

Objectives Of The Presentation
  • 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
Why Should you Attend
The new EU Clinical Trials Regulation will replace the European Clinical Trials Directive (2001/20/EC). The new guideline was originally due to come into effect in 2016, however the implementation has been delayed until the new portal and clinical trial database have been completed and audited.

Key aims of the new regulation are to harmonize procedures for carrying out clinical trials across the EU and to simply the clinical trial approval dossier through submission through a new clinical trial database and portal. Guidelines for enacting the new regulation are also being prepared in a number of areas including inspection, investigational medicinal product and trial documentation etc.

This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

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 analyze clinical trial samples
  • Project management
  • Sponsors and non-commercial sponsors
  • Consultants
  • Laboratories analyzing samples from clinical trials
  • Regulatory affairs personnel & Legal and regulatory authorities.

For Registration


Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont 94536

Starts April 25, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896