Strategies for conducting and managing clinical trials, as well as operational issues of a clinical research project will be examined. Effective methods for organizing data and quality assurance will be explored as well as end of trial practices, safety reporting, and the preparation of scientific documents. Topics in leadership will also be examined including management of resources, risk and professional conflicts. Pre-requisite: ACR 103
No Scheduled Class Meetings, January 16 - April 9 (Online)
Location:
ONLINE
Instructor:
Lawrence Reiter
Notes:
Please note registering after the course start date may delay course access and does not permit exceptions to coursework due dates, late textbook purchases, or the refund policy
Instructors
Sergio Corenstein
David Corenstein has 30 years of experience in the pharmaceutical industry in departments such as clinical research, marketing, sales and pharmacy. Over the past 20 years, David worked in Argentina and Canada for the most prestigious international contract research organizations in the international clinical research industry.
He worked in all phases from I to IV and all therapeutic areas including CNS, cardiology and oncology. In addition to his life and immigration experience, David has the need and passion to share the knowledge and skills to succeed in the Canadian clinical research market with the new CRA generations.
Lawrence Reiter has almost 20 years’ experience in the Pharmaceutical Research Industry in Clinical Operations, Project Management, Quality Assurance and Compliance. His experience includes monitoring and project management across a wide variety of therapeutic areas to include drug and device studies across all phases.
Lawrence has worked in multiple regions around the world and manages global studies in over 40 countries. In addition, he is accredited by and remains in good standing with the Society for Quality Assurance as a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP).
Lawrence is an experienced lecturer in GCP having been directly involved in the setup and running of a non-profit training organization in South Africa that provided training across global regions to both Sponsor and site staff.
