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Compliance with EU Regulation for Clinical Trials-OnlineWebinar

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

Online Event

  • Apr 2017

    25 Tue

    10:00AM

  • Apr 2017

    25 Tue

    1:00PM

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Compliance with EU Regulation for Clinical Trials-OnlineWebinar

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

Fremont

No tickets available

Description
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

http://onlinecompliancepanel.com/webinar/COMPLIANCE-EU-REGULATION-CLINICAL-TRIALS-506624/APRIL-2017-ES-EZEVENT


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

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