Event Details

Virtual Workshop - Overview of Aggregate Reports-Classification, Significance, and Industry Challenges

04-05 November 2022, 10:00am to 5:00pm

Indian Society for Clinical Research Presents

Virtual Conference on 04 and 05 November 2022

Title: Writing of Aggregate Reports (PADERs, PBRERs, DSURs, and RMPs)

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 conference 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 conference 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.

Conference Organizers: Asha Mathew Liju (Parexel) (Conference Lead), Rajneeta Roy (Eli Lilly) (Conference Co-Lead), Sabika Rizvi (IQVIA), and Navneet Sonawane (LabCorp).

Scientific Faculty: Nalin Taneja (Parexel), Vinay Dubey (Syneos), Farzana Banu (Parexel), Rupesh Thorat (SIRO), Ashish Adgaonkar (Novartis), Rajneeta Roy (Eli Lilly), and Navneet Sonawane (LabCorp).

Convener: Anushila Vaishali (Eli Lilly)

 Conference Agenda:  

  • Keynote address
  • Introduction to PADERs/PAERs and writing of PADERs/PAERs
  • Introduction to PBRERs and DSURs and writing of PBRERs and DSURs
  • Introduction to RMPs and writing of RMPs
  • Impact of EU CTR Regulation (EU) 536/2014 on aggregate reports
  • Benefit-risk management
  • Development of Aggregate Reports - Project Management Tips and Best Practices
  • Panel discussion

The conference will be held virtually.

Conference time and dates:

Friday, November 4th, 2022 – 10:00 am to 5 pm IST

Saturday, November 5th, 2022 – 10:00 am to 4:00 pm IST

Agenda

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