Pharma Regulatory Writing Webinar Series: Composition of Completed and Detailed CSRs and Narratives
Two 1 Hour and 5 Minute Videos | Lynne Munno, Sanofi-Aventis
Each CSR is a distinctive and complex document composed to support the efficacy and safety claims showcased throughout the approval dossier. While health authorities and guidelines state that CSR should remain a responsible length to showcase all vital data, the overarching aim for CSRs is to portray trial data to reviewers succinctly, accurately and clearly. It is vital for content authors to have a comprehensive understanding of the guidelines that form the structure for the generation of CSRs, as creating thorough and compliant CSRs will idyllically decrease regulatory review times and push innovative treatments to the market faster.
This pharmaceutical regulatory writing webinar series will be divided into two courses with the first portion focusing on CSR document development and the second on CSR narrative composition and appendices. Participants will gain a better understanding of CSR strategy and execution through the practical experiences and insight of a seasoned regulatory writer. Common themes to be discussed in both courses include current standards and guidelines outlined by ICH E3, project planning, writing and review processes, strategic meetings, project and vendor management.
Participants that will find this webinar most beneficial will be those involved in pharmaceutical and biotechnology companies. Job titles of attendees that will be most applicable for this session will be:
- Medical Writers
- Regulatory Writers
- Regulatory Affairs
- Regulatory Operations
- Submissions Specialists
This webinar was presented in two parts. Both parts are available for purchase and download.
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
For close to 10 years, Lynne has been working in the pharmaceutical industry as a medical writer in a variety of therapeutic areas, working on clinical documents for regulatory agencies and investigators, among other audiences. Lynne is currently a Principal Medical Writer at Sanofi working in the oncology division. She is responsible for writing and overseeing all clinical documentation for 5 different early- and late-stage compounds targeting both blood and solid tumor cancers. Prior to this, Lynne has held medical writing positions both in the pharmaceutical industry (AVEO Oncology and Alkermes) and in clinical research organizations (Quanticate and ORA, Inc.).
In her career, she has contributed to 2 oncology new drug application submissions, has written and contributed to approximately 70 clinical study reports, and has worked on a variety of other clinical regulatory documents, including but not limited to investigational new drug applications and Investigator Brochures. Lynne is a graduate of the University of Connecticut (B.A. in English and Sociology), University of Massachusetts Dartmouth (M.A. in Professional and Technical Writing), and the University of Sciences in Philadelphia (M.S. in Biomedical Writing).
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