Highlights: The clinical trial protocol is one of the most important regulatory documents in clinical research. Different protocol templates exist that serve different purposes during drug development. In the current era of automation, protocol development can be optimized through use of eProtocol applications, closely interlinked with the use of specific protocol libraries and master protocols. Navigating through EU CTR regulations and assessing the impact of the COVID-19 pandemic and beyond; medical writers need to be agile and require strong leadership skills to influence, lead, manage change and promote lean writing practices during protocol writing. Not only does a medical writer develop a protocol, but the protocol develops the medical writer.
The aim of this interactive workshop is to discuss pertinent themes related to the clinical trial protocol. The intended audience includes medical writers who already have experience in protocol writing, as well as any other participants who are involved or interested in the development of this regulatory document. At the end of the workshop the participants should understand the forms of protocols in development, the growing need for the medical writer to be agile and adapt in an ever-changing- environment of regulations, and skills that can be developed and fine-tuned on the protocol writer journey.
Who should attend: Regulatory medical writers, clinicians, trial managers, and anyone who is involved in writing clinical trial protocols. This workshop is also open to publication writers, scientific writers, regulatory affairs specialists, clinical trial investigators, research scholars, scientists, and health care professionals from pharmaceutical industry, contract research organizations, government agencies, non-profit organizations/associations, and academia, medical, pharmacy or life-science students or professionals interested in making a career in clinical research.
Convener: Anushila Vaishali (Eli Lilly)
Workshop Organizers: Anick Vandingenen (Janssen), Hanalie Van Passel (Janssen), Marjan Moreels (Janssen), Vinod Singh (TCS).
Scientific Faculty: Anick Vandingenen (Janssen), Hanalie Van Passel (Janssen), Senyo Ofori (Janssen), Tatiana Piotroff (Janssen), Charu Misra (Janssen).
|
Registration fees (By 31st August 2022)
|
Student / Academia – Rs. 500/-
|
ISCR Member – Rs. 1000/-
|
Non-ISCR Member – Rs. 1200/-
|
|
Registration fees (After 31st August 2022)
|
Student / Academia – Rs. 750/-
|
ISCR Member – Rs. 1200/-
|
Non-ISCR Member – Rs. 1500/-
|