Practical Document Writing and Management (Pharmaceutical)The Organisation for Professionals in Regulatory Affairs
Practical Document Writing and Management (Pharmaceutical)
A two-day, skills-based course on the theory and practice of writing optimal regulatory documents and communications for those working in the pharmaceutical industry.
This course will look at the theory and practice of writing clear and precise regulatory documents and communications including:
- The importance of good writing, language and style
- How to organise/build a document
- Managing a dossier and the process from data to submission
- What everyone needs to know about writing regulatory communications and overviews
- Writing technical reports
- Expert tips for authors using Word
- Hints and tips from a regulatory authority
Suitability - Who should attend?
- Regulatory Affairs Professionals in the pharmaceutical industry writing reports and dossier sections
- Related technical experts who write regulatory documents
Outcome / Qualification etc.
Benefits to participants
- Meet and learn from experts in the field
- Learn by doing - participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Develop skills to increase performance and support career progression
- Learn to write and construct regulatory submission documents
- Get fewer corrections from your colleagues and enhance your reputation for good work
- Get through internal review faster
- Minimise questions from regulators
- Take a course designed by professionals for professionals with a proven track record
Training Course Content
Day 1: The Theory
- Introduction and AIM
- Working with teams
- An Agency’s perspective
- Case Study
- Case Study presentations & discussion
- Regulatory Communications
Day 2: The Practice
- Project Management
- Technical reports
- Dossier Management
- Regulatory Operations and Publishing
- MS Word - things all authors should know
- Writing Overviews
The full tuition price for Members is 925 GBP. The price for Non-members is 1095 GBP
The Organisation for Professionals in Regulatory Affairs (TOPRA)
The Organisation for Professionals in Regulatory Affairs (TOPRA) has encouraged excellence in the area of regulatory affairs for pharmaceuticals, veterinary medicines and medical devices since 1978. TOPRA's mission is to represent and promote the profession of healthcare regulatory affairs globally....
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