Public Release of Clinical Information Symposium
Public Release of Clinical Information Symposium
Registered attendees will receive official Microsoft Teams link to join the Symposium on Friday, March 04, 2022.
If you have not received the invitation by 3 pm on March 04, please contact the CAPRA administrator ( administrator@capra.ca ).
Registered attendees will receive presentations from Queenia Lee.
Registration will be open from February 4th, to March 3rd, 2022.
Click here for the brochure.
The CAPRA Symposium Committee will host a half-day virtual interactive session highlighting Health Canada’s Public Release of Clinical Information (PRCI) initiative.
Health Canada's objective is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes following the completion of Health Canada's regulatory review process while adhering to Canada's Privacy Act.
Health Canada will provide an update on Health Canada's release process, including requests made through the portal, and an overview of the timelines. Health Canada will also outline recent disclosure of COVID-19 product information and international harmonization activities with the EMA.
This Symposium will also share Industry experiences and provide attendees with an opportunity to raise questions with all speakers on this topic.
This event will be of interest to:
· Regulatory Affairs professionals from medical devices, pharmaceuticals and biologics
· Clinical Research and Contract Research Organizations
· Clinical Data Management/Pharmacovigilance
· Research and Development
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CAPRA Symposium Committee
Speakers / Panelists
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Etienne Thomas
Acting Team Lead, Information Science and Openness Division, Health Products and Food Branch of Health Canada
Etienne Thomas
Acting Team Lead, Information Science and Openness Division, Health Products and Food Branch of Health Canada
Etienne has been with Health Canada since 2016 and with PRCI since 2020. Prior to joining PRCI, Etienne acquired experience reviewing clinical trial applications in Health Canada's Biologics and Radiopharmaceuticals Drugs Directorate, as well regulatory assessment and review in the Cannabis and Controlled Substances Branch. He has an MSc in Pharmaceutical Sciences: Drug Development from the University of Montreal.
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Lorella Garofalo
Head of Head of Regulatory Affairs for Pfizer Canada
Lorella Garofalo
Head of Head of Regulatory Affairs for Pfizer Canada
Lorella Garofalo is Head of Regulatory Affairs for Pfizer Canada. She joined Pfizer Canada in 2001 and prior to leading the regulatory function held leadership roles in clinical research and medical affairs with responsibility for multiple therapeutic areas. Before joining Pfizer, Lorella worked for 6 years as a drug assessment officer at the Therapeutic Products Directorate (TPD) at Health Canada.
Lorella obtained a BSc (Honours) in Biochemistry and a Ph.D. from the Department of Pharmacology and Therapeutics at McGill University. She completed post-doctoral research training at the National Research Council in Rome, Italy, and the Royal Victoria Hospital/Montreal Neurological Institute. She maintains an academic appointment at McGill University as an affiliate member of the Department of Pharmacology & Therapeutics and has served as a member of the board of directors/advisory councils for various Canadian non-profit research organizations. Lorella is also a member of the Regulatory Affairs committees of Innovative Medicines Canada and BIOTECanada.
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Lora Killian
Clinical Trial Transparency and Disclosure Lead, Pfizer
Lora Killian
Clinical Trial Transparency and Disclosure Lead, Pfizer
Lora has 20+ years of business experience, including more than a decade of pharmaceutical industry experience. She started her career in the military serving four years of active duty in the Medical Service Corp for the U.S. Army. In her first pharmaceutical industry position, Lora served for 4 years as Director of Operations for a small medical writing company. She transitioned to Transparency and Disclosure in 2014. During her 8 years in Transparency and Disclosure, Lora has overseen the delivery of 5500+ redacted and anonymized documents to support European Medicines Agency Policy 0070, Health Canada Public Release of Clinical Information, other global disclosure regulations, and broader corporate transparency policies for many sponsors.
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Elliot Zimmerman
CEO of Real Life Sciences
Elliot Zimmerman
CEO of Real Life Sciences
Elliot is CEO at Real Life Sciences since 2020. Elliot retains a pharmaceutical and clinical technology background with prior experience as COO at goBalto, Inc prior to its acquisition by Oracle in 2018. Elliot serves on the Steering Committee of CRDSA (Clinical Research Data Sharing Alliance) and is passionate about accelerating the clinical trial process and making it easier for pharmaceutical companies to share and disclose trial results.
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Tharany Ganesh
Head of Regulatory Affairs, Patient Safety and Quality Assurance, AstraZeneca Canada
Tharany Ganesh
Head of Regulatory Affairs, Patient Safety and Quality Assurance, AstraZeneca Canada
Tharany Ganesh is the Head of Regulatory Affairs, Patient Safety, and Quality Assurance at AstraZeneca Canada. Tharany has been with AstraZeneca since 2006, holding progressive roles in Regulatory Affairs. She has worked in several different therapy areas including Oncology, Cardiovascular, Respiratory, Infectious Diseases, Gastrointestinal, and Neuroscience during her career at AstraZeneca. Tharany holds a Master of Biotechnology degree from the University of Toronto, and an Honours Bachelor of Science degree from the University of Waterloo.
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Julie Holtzople
Sr. Director of Clinical Transparency & Data Sharing, AstraZeneca Global
Julie Holtzople
Sr. Director of Clinical Transparency & Data Sharing, AstraZeneca Global
Julie is the Sr. Director of Clinical Transparency & Data Sharing for AstraZeneca. Julie received her Bachelor of Science in Business Administration at Virginia Polytechnic Institute. Prior to her time in AstraZeneca Julie was a management consultant in health care. Julie has been with AstraZeneca for 14 years. Today, Julie is focused on the implementation and delivery of new transparency policies, regulations, tools, and general best practices as they emerge in the industry. As part of her role, Julie is actively involved in several industry organizations that are focused on establishing best practices within Clinical Trial Transparency. Julie has been particularly focused on the global implementation of the Document Anonymization leading the delivery of 15 plus packages across the EU and Health Canada to date.
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