Technical and Regulatory Writing for FDA-Regulated Industries
Are you familiar with FDA documentation requirements for Investigational New Drug (IND), Drug Master Files (DMFs), Non-Disclosure Agreements (NDAs) for medical device and pharmaceutical manufacturers? Do you want to expand your knowledge of writing for regulated industries to bring more value to your current employer, or are planning to transition into the growing medical device/pharma industry? If so, the Orange County chapter of the Society for Technical Communication (OCSTC) is bringing an exciting and informative two-day seminar on technical and regulatory writing to you this June.
Regulatory professionals have to write highly technical documents for a variety of audiences. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This two-day seminar addresses best practices, and regulatory strategies on how to write effective/FDA-responsive documents. The agenda covers everything from routine topics such as meeting minutes and correspondence notes to highly-sophisticated nonclinical and clinical study reports, and regulatory submissions to the FDA, European Medicines Agency (EMA), Health Canada, and other regulators.
Seminar sessions will provide practical tips using examples on how to organize and deliver information in clear and readable documents, and how to edit, format, present and publish technical regulatory documents for most favorable reception by the regulatory agencies. Sessions will also address rules for writing documents intended for electronic submission to regulatory agencies. This one-of-a-kind seminar will provide technical, practical, logical and logistical tips for regulatory writers at all skill levels.
OCSTC is hosting this event and providing attendees with breakfast and lunch, as well as mid-morning and mid-afternoon refreshments and snacks both days. Attendees are invited to a reception at the end of the first day.
Who will benefit:
- Regulatory Affairs professionals preparing IND, DMFs, NDAs, and other document submissions
- Medical and Technical Writers
- Project Managers and Directors
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control Managers
Seminar Agenda Highlights:
- Expectations for regulatory documents
- Ground rules for writing, formatting and updating content
- Templates and style guides
- Writing for the audience
- Quality control of documents
- Common regulatory documents
- Common technical documents Read More
About the Speaker:
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and biotech products. He is lead consultant at Brij Strategic Consultations. Dr. Kumar is also the Founder and Managing Partner in AmarexBioVentures, an investment company specializing in FDA-regulated products. Read More