London, United Kingdom, March 10, 2016 --(PR.com
)-- In light of the new EU regulation, 5362014, being implemented in May 2016, it is imperative you are up to date with the latest requirements evolving around the documentation of clinical trials.
Through interactive discussions and group activities, this full-day CPD-credited masterclass will outline: regulations relating to Trial Master File (TMF), including best practice guidance and the latest thinking from legislators and regulators as well as how clinical study records can be created and managed in both the immediate- and long-term to ensure the timely availability of an inspection-ready TMF.
Benefits of attending:
• Understand the requirements for clinical study records
• Comprehend how records can be managed more effectively
• Learn how to make best use of clinical study records to enhance information sharing and facilitate more efficient operations
• Improve inspection – readiness to avoid resource-intensive preparations when notified of impending audits and inspection
This masterclass is CPD certified meaning you can get recognised for the learning you perform with SMi. A CPD accredited certificate will be given on successful completion of this masterclass.
This exclusive session will be led by Russell Joyce, Director, Heath Barrowcliff Consulting Ltd. Russell has over 20 years’ experience in records management across a wide variety of industries (including pharmaceuticals).
SMi: "Can you give us a top tip on clinical trial documentation?"
RJ: "Not to regard the selection of an eTMF as the solution: this is to confuse the start line for the finishing line. The introduction of an eTMF is not simply a matter of implementing technology but much more a matter of change management, of user engagement and opportunities for process optimisation."
Visit the event website www.smi-online.co.uk/clinical-documents.asp to download a pre-masterclass interview with Russell as he gives a deeper insight into clinical trial documentation as well as further information on the masterclass.
For more information or to register visit the event website www.smi-online.co.uk/clinical-documents.asp or contact Matthew Apps on +44 20 7827 6093 or email: firstname.lastname@example.org.
Mastering Clinical Trial Documents Masterclass
Phone: Matthew Apps on +44 20 7827 6093
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the worlds most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk.