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November 14, 2012

The Changing Role of the QP and Regulatory Challenges That Impact the Clinical Supply Chain

Keynote Speaker for this Event:
  • Ronnie Constable, Director of Quality, Fisher Clinical Services   Learn More
  • The Changing Role of the QP and Regulatory Challenges That Impact the Clinical Supply Chain

    The globalization of clinical trials presents challenges to all those involved in clinical trial conduct around the world. The role of the Qualified Person is key to ensuring the smooth release of IMP in accordance with regulatory guidelines such as the EU Directive.

    The purpose of this webinar is to discuss recent changes in regulatory requirements and their impact on the clinical supply chain, including:

    • The QP release process
    • Considerations when using comparators
    • Cold chain/temperature sensitive materials

    We will discuss ways in which a Sponsor can take steps to address these challenges. The result is a defined approach towards understanding and interpreting new regulatory requirements so as not to compromise on the timelines of a clinical trial.

    THIS PROGRAM IS INTENDED FOR:

    Senior level executives in R&D, Quality and Clinical Supply functions for pharmaceutical/biotech companies worldwide.

    ABOUT OUR SPEAKER:

    Ronnie Constable, Director of Quality, Fisher Clinical Services

    Ronnie Constable has been the Director of Quality for Fisher Clinical Services since January 2009. With over thirty years experience in the industry, a passion for the importance of maintaining high quality standards and with a true appreciation of new regulatory requirements and how they impact on the clinical supply chain, Ronnie is best placed to present this webinar. His career path includes Analytical Chemist at Forensic Science and Medicines Testing Laboratories; Head of Analytical Chemistry and Degradation Profiling with Syntex Research, subsequently Roche; Vice President of Quality and Compliance with Quintiles; Vice President of Quality with Aptuit. In addition, Ronnie has been a practicing QP for over 20 years.

    Ronnie holds a BSc (Hons) in Chemistry from Heriot Watt University, Edinburgh and a Diploma in Management Studies (DMS) from Napier University, Edinburgh. He is an ex Chairman of BARQA and an elected Fellow of both the Royal Society of Chemistry (FRSC) and the Chartered Quality Institute (FCQI) with Chartered status of both professional, scientific associations.

    OUR XTALKS PARTNER FOR THIS EVENT:

    Fisher Clinical Services is the world's leading provider of clinical supply chain services.

    With a network of cGMP facilities strategically located across the globe to support the conduct of clinical trials, we offer worldwide support for all aspects of clinical supply management including comparator, co-medication and ancillary supply sourcing, packaging, labeling, distribution, storage, through to returns and destruction. With more than twenty years of experience exclusively focused on clinical trials, we can offer guidance and full logistics support across all types of clinical programs and projects.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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