Day one of the symposium included a variety of presentations from industry experts. Kim McDonald Taylor (McDonald Taylor Consulting), opened the meeting with a presentation on Health Canada’s GUI-0100: Draft Guidance Document – Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”. Kim was followed by Barb Lazare (GlaxoSmithKline), who discussed electronic medical records and the trials and tribulations that they can present. Mike Luksic, Intrinsik Corp., discussed the art of study monitoring and Michelle Thompson (FDA Quality and Regulatory Consulting), presented on the due diligence required in vendor assessment. The final presentation of the day was given by Chris Wubbolt (QACV Consulting), on the approaches that can be used for auditing software vendors. Yasser Farooq, representing RQA, closed the meeting with a brief overview of the EU General Data Protection Regulation (GDPR) and the implications for Canadian and other non-EU businesses.
The second day of the symposium was dedicated to a workshop on data integrity which was organised and delivered by Chris Wubbolt, The workshop was very informative and included real life case studies and several interactive exercises.
Overall the meeting was a great success. The content of the presentations and the experience of the presenters gave the opportunity for discussion and knowledge sharing. The Canadian Regional Forum of RQA would like to thank QACV Consulting for sponsoring the event.