Indian Society for Clinical Research Presents
Virtual Workshop on 04 and 05 November 2022
Title: Overview of Aggregate Reports-Classification, Significance, and Industry Challenges
Highlights: Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Aggregate reports or safety reports such as Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs) play an important role in the assessment of benefit-risk profile of a drug.
The aim of this workshop is to provide an overview of development of aggregate reports, discuss best practices, and project management tips. The intended audience include Medical Writers who are new or have aggregate report writing experience, as well as any other participants that are involved or interested in the development of aggregate reports.
Who should attend: Regulatory Medical Writers from pharmaceutical industry and contract research organizations. This worshop is also open to Publication Writers and Scientific Writers 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.
Workshop Organizers: Asha Mathew Liju (Parexel) (Workshop Lead), Rajneeta Roy (Eli Lilly) (Workshop Co-Lead), Sabika Rizvi (IQVIA), and Navneet Sonawane (LabCorp).
Scientific Faculty:
Bindu Narang (LabCorp), Nalin Taneja (Parexel), Vinay Dubey (Syneos), Farzana Banu (Parexel), Rupesh Thorat (SIRO), Ashish Adgaonkar (Novartis), Rajneeta Roy (Eli Lilly), Sivanandan Sivaraj (AZ), Darshil Panchal (IQVIA), Navneet Sonawane (LabCorp).
Convener: Anushila Vaishali (Eli Lilly)
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Registration fees (By 30th Sep 2022)
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Student / Academia – Rs. 500/-
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ISCR Member – Rs. 1000/-
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Non-ISCR Member – Rs. 1200/-
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Registration fees (After 30th Sep 2022)
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Student / Academia – Rs. 750/-
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ISCR Member – Rs. 1200/-
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Non-ISCR Member – Rs. 1500/-
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