SOURCE: Xtalks

Xtalks Webinars

February 01, 2016 09:00 ET

GCP Training: How to Survive a European Medicines Agency (EMA) Audit

TORONTO, ON--(Marketwired - February 01, 2016) - Xtalks eCademy launches special two-hour online training course to help clinical research teams, including study sites, sponsors and CROs, better understand and respond appropriately to, an EMA audit in the European market.

  • Online Training: Friday, February 26, 1:00 - 3:00 pm EST

This GCP training will prepare clinical research sites, pharmaceutical sponsors and clinical research organizations in the field of international clinical trial management, through a detailed review of the complex regulations of the European Medicines Agency, including the recent ICH-GCP-E6 Guidelines. We will discuss the pitfalls that you may experience and how best to avoid them.

We have to remember we are living in a global economy. 

It is not enough to understand FDA regulations;

we need to fulfill the expectations of the EMA as well. 

To ensure continuing prosperity in the global economy,

nothing is more important than the development and application

of knowledge and skills through continued education.

Dianne Dalton

Three key objectives:

  • Demonstrate knowledge on navigating the regulatory environment for international clinical trials through EMA regulations and inspection guidelines 
  • Discuss common pitfalls in international clinical trial management 
  • Identify the necessary steps needed to prepare for, and survive, an EMA inspection

Practical, convenient, engaging and fun, this online course can be accessed from your home or office and is equipped with real-world experience and armed with the latest tips, tools and best practices to ensure you and your teams' ongoing success. Registrants will have the opportunity to participate in online polls and engage with fellow participants, with frequent key learning concepts reinforced throughout the training, followed by an interactive Q&A session. Participants will earn a Certificate of Completion equal to Education Credits of 2.0 post training.

Instructor: Dianne Dalton has 20 years' experience in international clinical development and trial management and is skilled in strategic and tactical decision-making, line management, resource planning, timeline negotiation, colleague development, performance management and colleague engagement. Dianne also has extensive experience overseeing vendors within a matrix environment ensuring they meet Pharma/ICH/GXP/EMA expectations. She is experienced in the design, planning and implementation of multi-center international clinical trials, protocol writing, case report form design, budget negotiations, regulatory oversight, investigator recruiting, study staff training and auditing. Dianne is a Safety Management and Review Committee participant and an expert in international and domestic Inspection Readiness.

Xtalks eCademy: Interactive Online Training Courses and Workshops:

Developed through ongoing research and in-depth dialog with your peers, Xtalks eCademy provides a unique, best-in-class virtual learning experience for companies and individuals who wish to stay informed about recent developments in the life science industry. Our interactive online training courses are delivered by pharmaceutical, biotech and medical device industry experts to equip you with the knowledge needed to excel in your field of interest.

Register today and take the first step to ensuring you're prepared for an EMA audit!

For more information, visit:

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