This workshop covers the Periodic Safety Update Report (PSUR) and Periodic Benefit-Risk Evaluation Report (PBRER) formats. Participants will gain a working knowledge of the International Conference on Harmonisation (ICH) E2C guidelines for purposes of planning and writing periodic safety reports. Practical issues, such as challenges, planning, and writing of reports using clinical project management skills will be addressed. This course has been developed for those who have no previous training in writing PSURs or PBRERs as well as those who have a basic knowledge which they wish to improve, and for those who are familiar with the old PSURs, but now need to learn more about the new PBRERs.
· Introduction to post marketing periodic safety reporting regulations
· The PSUR and the PBRER
· Periodic Safety Update Report (PSUR) International Council on Harmonization (ICH) Topic E2C(R1)
· Periodic Benefit-Risk Evaluation Report (PBRER) International Council on Harmonisation (ICH) Topic E2C(R2)
· Periodic safety update reports format and content
· Examples of PSUR/PBRER
· Preparation and submission of summary reports for marketed health products Health Canada Guidance Document
Who should attend:
· Staff from the regulatory authorities
· Regulatory inspectors and auditors
· Medical writers and consultants
· Regulatory Affairs Associates and Managers
· Drug Safety Associates, Officers, and Managers
· Clinical Research Associates and Managers
· Personnel involved in Medical Information Department
· Principal investigators and research team in hospitals and CROs
· Company personnel initiating a Drug Safety team or having concerns regarding ADR compliance
SPEAKER: Pr. Peivand Pirouzi
Peivand holds a Ph.D in Physiology and Biophysics School of Medicine, University of Sherbrook, and an MBA from American Business Administration Institute, and he is accredited by the Canadian Council of Pharmaceutical Education with certificates in Evidence Based Medicine, Psychiatry, and Management.
Peivand’s industrial experience includes Wyeth/Pfizer, ApoPharma/Apotex, as well as collaborations with EliteMed and Medipure Pharmaceuticals. His government and corporate training experience covers companywide pharmaceutical and sales training on a multitude of subjects. He has extensive pharmaceutical teaching experience to personnel ranging from Health Canada Inspectorate (in pharmacovigilance) to pharma industry organizations such as Nestle, Teva, Biopharma Services, 3M, Medipure Pharmaceuticals and Patheon.
He has authored more than 65 scientific realizations, including 12 publications in the National Library of Canada, articles in peer-reviewed journals, oral and poster presentations, and more than 100 technical and scientific reports.
|Student Ticket:||$250.00||— Sold Out|
|Basic Non-Member Single Ticket:||$525.00||— Sold Out|
|Basic Non-Member Group Tickets (5+):||$450.00||— Sold Out|
|Pro/Pro Plus Member Single Ticket:||$495.00||— Sold Out|
|Pro/Pro Plus Member Group Tickets (5+):||$420.00||— Sold Out|