regulatory writing Important topicc.pptx

Regulatory writing

1. Regulatory Writing Brief Introduction and Type of Documents

2. Regulatory Writing  Regulatory writing is part of the clinical research which deals with the documents meant for the submission to the Regulatory Authorities (like USFDA, EMEA, TGA, Health Canada, ANVISA etc).  So, these are the documents required in the approval process for the drug, devices, and biologics by the various Regulatory Authorities.  The entire process drives the demand for well-written, standards- compliant, clear, and concise documents that reviewers can easily read and understand.  Latest developments, new and updated guidelines issued by regulatory authorities are the core attributes of the regulatory writing.

3. Requirement  Regulatory documents are submitted to track and evaluate the ethical and procedural conduct of a trial and the quality of the data that is produced during clinical trial.  Regulatory documents demonstrate the compliance of the Investigator, Sponsor and Institutional Review Board (IRB)/Independent Ethics committee (IEC) with the standards of Good Clinical Practice.  Regulatory documents demonstrate the compliance with all applicable regulatory requirements since inception (preclinical phase) to development (Clinical phases from 1 to 4) of the drug products.

4. Regulatory Writer: Essential Qualities  Academically sound with a scientific or medical degree  Good liaising skills to involve with different working departments like clinicians, statisticians, study management team, investigators, pharmacokinetics/pharmacodynamics, regulatory, safety etc.  Good understanding of drug development processes and regulation, clinical trial designs  Clear understanding of the latest global regulatory requirements, ICH and GCP  Good therapeutic area knowledge  Logical thinking and thorough research

5. Regulatory Writer: Essential Qualities (Contd.)  Must understand the data to interpret it correctly  Must have ability to summarize the statistical findings  Must have knowledge to work on structured templates, clear and concise writing, different standard style guides  Good proof-reading ability and critical review of the developed content for quality, grammar, punctuation, flow, compliance, and style guide used  Must have strong editing and formatting capability

6. Regulatory Documents t The various regulatory documents which needs to be submitted to the Regulatory Authorities for product approval are given below: Investigational New Drug form ( IND form ) Clinical Study Protocol Informed Consent Forms Case Report Forms Clinical Study Reports (CSRs) Investigator’s brochure (IB) Safety Narratives

7. Regulatory Documents (contd.) Formulary dossiers Periodic Safety Update Report (PSUR) development safety update report (DSUR) Common Technical Documents (CTD) Risk Management Plan (RMP) Risk Assessment Plan (RAP) Summary of product characteristics (SmPC)

8. Career Options and Benefits The potential employers for the regulatory writers are:  Pharmaceutical/biotech companies  Different contract research organization (CRO)  Medical Communication agencies The regulatory writers can also work as a Freelancer The Key benefits are:  Different variety of projects with different therapeutic area  Home-based or remote working  Clear and progressive pathway  Good mentorship and training  Good financial benefits

9. Benefits and Drawbacks of Freelancer The key benefits are:  You are your own boss  Working flexibility with preferred time and work  Potential to earn more The key drawbacks are:  Lack of continuous work  Losing the benefits of a permanent employment (Insurance, pension, regular salary)  Limited sources of discussion/training which can be done in- house

10. Thank You So, combine your passion for learning about new science, new therapeutic area and medicine with your enjoyment of writing