What is the Future for the Clinical Trials Directive?

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Harmonisation, harmonisation, harmonisation - this is the resounding feedback from our industry-wide survey focusing on GCP, auditing and compliance standards.  Everybody felt that the Directive is out of date and there needs to be more standardisation between and within regulatory authorities as to what constitutes GCP, where the responsibilities lie between sponsor and CRO as well as data collection approaches and trial master file management.

Pharma IQ (a division of IQPC) has commissioned an exclusive whitepaper, which delves into the past, present and future of the Clinical Trials Directive, its relevance today and what industry leaders see as the possible remedies to harmonisation could be, from creating a single agency through to voluntary schemes - what do you think the solution is?

One comment from the whitepaper;  “We are all concerned that there not be a two tier system for commercial & non-commercial sponsors.  It is unethical to allow different standards depending upon whether it is commercial or not.  The public deserve equal protection of their rights no matter who is performing the study.”

So with the Directive under review and industry feedback submitted, what will be the outcome and what does the future hold for clinical trials regulations?

The GCP, Auditing and Compliance conference is being held in London on November 29th - 1st December to address these issues and much more, with first hand insight from one of the most crucial regulatory bodies in the joint inspection scheme, BfArM and experts throughout the industry.  Don't miss your chance to explore strategies to improve the efficiency of your auditing and reduce costs through a lesson in how to develop a risk based model from the pioneers, Roche and Bayer.

To access the whitepaper free of charge email us at enquire@iqpc.co.uk or visit http://www.gcpauditingcompliance.com/ to request your copy. We would love to hear your comments on the whitepaper and the issues that it addresses, let us know your thoughts directly at nicola.ambler@iqpc.co.uk or post comments at http://events.linkedin.com/Good-Clinical-Practice-Auditing/pub/355885.


Editors Notes.
IQPC has an established reputation for delivering the highest standard of industry specific conferences, seminars and internal training programmes. We aim to keep business executives up-to date with the forefront of their industries’ trends, technological developments and regulatory landscape.

For any more information please contact: Nicola Ambler, +44 (0)20 7368 9300 nicola.ambler@iqpc.co.uk or visit www.gcpauditingcompliance.com.

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