2023-2024 SOCRA Annual Report - Flipbook - Page 18
SOCRA 2021 ANNUAL REPORT
EDUCATIONAL OPPORTUNITIES
2020 - 2021
FDA CLINICAL TRIAL REQUIREMENTS,
REGULATIONS, COMPLIANCE, AND GCP
CONFERENCE
CONDUCTING CLINICAL TRIALS IN CANADA
CONFERENCE
This two-day conference, jointly sponsored with the U.S. FDA,
shares information regarding clinical research regulations
and GCP guidelines, and discusses methods to aid the
research professional in their practice. This conference is
designed to enhance the participant’s understanding of the
mission, responsibilities, and authority of the FDA and to
encourage interaction with FDA representatives. Hear
directly from FDA representatives, as they share information
with the regulatory community to facilitate the
understanding of regulations, guidelines and practices, and
to suggest methods and opportunities to enhance research
professionals product development understanding. This
conference highlights the following areas:
FDA Regional BIMO Offices Roles, Structure and
Responsibilities
Modernizing of FDA’s Clinical Trials / BIMO Programs
FDA’s Expectations for a Clinical Trial
Medical Device Aspects of Clinical Research
FDA Center for Biologics’ Regulation of Research
Adverse Event Reporting – Science, Regulation, Error and
Safety
Ethical Issues in Subject Enrollment
FDA Conduct of Clinical Investigator Inspections
Investigator Initiated Research
Meetings with the FDA - Why, When and How
Part 11 Compliance - Electronic Signatures
IRB Regulations and FDA Inspections
Informed Consent Regulations
When the Inspection is Over - Possible FDA Compliance
Actions
This conference, jointly sponsored
with regional BIMO offices of the
U.S. FDA, is designed to aid
Clinical Research Professionals’
understanding of the mission,
responsibilities and authority of
the FDA and to facilitate
interaction with FDA
representatives.
OFFERED
VIRTUALLY AND
IN-PERSON
A Uniquely Canadian Perspective for all Clinical Research
Professionals
Gregory Staios, MSc, CCRP
Professor, School of
Biological Sciences,
Seneca College
Program Chairperson
Jennifer Li, CCRP
Quality Assurance
Supervisor, Cancer
Clinical Research Unit,
Princess Margaret Cancer
Centre/University Health
Network
Program Chairperson
Answering requests from Canadian
members, SOCRA offers a program on
conducting clinical trials in Canada.
This program features sessions on
Health Canada’s regulations for
pharmaceutical and medical device
clinical studies. Speakers address
current trends in clinical research and
identify how these trends influence
clinical development now and into
the future. Speakers review ethical
challenges for research in the
Canadian regulatory environment; key
elements in preparing for a Health
Canada inspection and potential
corrective and remedial actions for
audit inspection findings. In addition,
the program reviews critical analysis
and risk management strategies to
mitigate cultural challenges
presented by multinational trials.
TransCelerate BioPharma: This ICH E6
GCP training meets the minimum
criteria for ICH GCP Investigator and
Site Personnel Training identified by
TransCelerate BioPharma as necessary
to enable mutual recognition of GCP
training among trial sponsors.
This conference offers a uniquely
Canadian perspective and will
assist all clinical research
professionals in improving their
skills and their understanding of
the responsibilities of conducting
clinical research in Canada.
OFFERED
VIRTUALLY AND
IN-PERSON
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