Synopsis
Indian Society for Clinical Research (ISCR) is pleased to announce workshop on “Lab Sample Management in
the world of Clinical Trials” on 27-Aug-2022 (Sat 9:30 AM to 3.30 PM IST). This workshop will provide a
platform for discussion on the Life cycle of Lab sample management and innovative developments in clinical
trials and clinical research. This workshop will involve extensive participation of individuals from clinical
research community who are focused on learning more about Laboratory sample management and its
growth.
The Clinical Trials and the policies are consistently evolving, along with development of new tools and
processes. This has in turn amplified the requirements of the way we conduct clinical trials, where tests are
performed in a time bound and highly planned environment. This workshop will cover the Life cycle of the
Laboratory sample management, the challenges involved in handling lab sample and kit delivery. The session
aims to discuss the current efficient processes used, advanced approaches to provide solutions in clinical
labs, which in-turn would benefit patients.
Lab data collected from subjects is one of the critical data that helps to evaluate patient’s health and safety,
thus an important parameter in conducting any clinical trial. There are various stages and steps involved in
the collection of Lab Sample. Impact on a single step from the vast procedure starting from Creation of Lab
Manual to Shipping of samples etc., will have a critical impact on the Clinical trial study and its outcomes.
Hence this workshop will cater to the discussion of the overall lifecycle and management of Lab Samples at a
ground level.
We plan to offer engaging presentations across 5 sessions with insightful Q&a and ways to interact and
connect with fellow attendees, speakers and sponsors.
We look forward for your participation in the “Lab Sample Management in the world of Clinical Trials”
workshop 2022.

Why to attend?
Attending the workshop is a novel possibility to develop the skills and cross functional knowledge from peers
who have multidisciplinary experience and knowledge to share with you. It will cover various sections such
as, Development and criticality of a Laboratory manual, Sample collection kits and their delivery, Handling of
Clinical trial samples and Innovations in Lab Sample management. When different expertise and capabilities
from Clinical research industry comes together, ideas and results are sure to develop in this workshop. This is
the best opportunity to reach other participants from Clinical Trials community that is from academics,
clinical research, various societies and also from pharmaceutical industries.

Who Should Attend
Students, Clinical Site staff, Pharmaceutical and Biotech industry professionals with their interests in:

• Clinical Research & Development
• Clinical Trial Management/Clinical Trial Supplies
• Data Management
• Central Labs
• Laboratory Sample Management

Registration starting soon.

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).

Registrations starting soon

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)