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RAPS Sponsored Webcast: Regulatory & Tech Advances in Drug Safety Reporting

Live webinar
Date
Thu, June 20th 2024
Time
11am ET

Meeting the escalating global demand for new medications requires expediting regulatory submission development. Documenting drug safety issues occurring in clinical research is a major aspect of regulatory and medical writing. Two major types of safety regulatory documents are the development safety update report (DSUR) and the patient safety narrative.

This webcast will discuss the latest regulatory requirements changes and artificial intelligence technology advances in drug safety reporting. The DSUR summarizes the safety information occurring during the clinical development of an investigational drug. Regulatory professionals in the pharmaceutical industry are often unaware of the recent changes in regulations that affect the country-specific requirements for DSURs. Recent examples include the EU requirements in the clinical trial regulation. China, the UK, and Canada have new requirements too. This webcast will summarize these regulations and highlight potential DSUR changes by the US Food and Drug Administration (FDA).

Registration Fees & Deadlines
Free

Learning Objectives

  • Understand the country-specific DSUR requirements released over the last year
  • Understand how this impacts the content/structure of the DSUR
  • Appreciate the potential upcoming US-specific DSUR requirements
  • Understand recurring challenges in patient safety narrative projects
  • Appreciate the potential of generative AI technology to facilitate narrative writing
  • Compare traditional solutions vs tech solutions for drug development

Who Should Attend?
All regulatory professionals involved in running clinical trials who act as either authors, contributors, reviewers, or approvers of DSURs. Likewise, medical writers, statistical programmers, regulatory affairs, and clinical development professionals will find this webinar useful.

Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Regulatory & Tech Advances in Drug Safety Reporting
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Speakers
Mary Pilkington
Mary Pilkington, PhD
Associate Director, Service Line Head, Certara
Mary Pilkington, PhD, has over 20 years of experience in regulatory writing. She is an expert in writing pharmacovigilance documents, including development safety update reports, periodic benefit-risk evaluation reports, periodic adverse drug experience reports, and risk management plans. She is process-driven, having created standard operating procedures and working instructions for pharmacovigilance documents, and is client-oriented, developing long-term governance relationships. She also has proven skills in training and developing junior writers to become pharmacovigilance document subject matter experts. She is an associate director and the service line head for safety/PV at Certara.
Reema SelvaRaju
Reema SelvaRaju, MSc
Associate Director, Patient Safety Narratives & Automation, Certara
Reema SelvaRaju is a microbiologist by training. She has over 15 years of experience in regulatory writing of narratives (pharmacovigilance and clinical study reports; CSR narratives), project management, and using automation technology. SelvaRaju works closely with clients to create custom solutions and ensure smooth project management. She currently leads the narrative space at Certara in the capacity of associate director.