Regulatorium offers the following seminars, on-site, for private clients. Some of the courses are also offered through Barnett for individual participants. Please see Upcoming Events for a listing of Barnett Seminars.
Two Day Seminars
- IND Submissions (including the IND in a CTD format)
- Global IND Submissions (Including EU and Canada CTA Process)
- Effectively Writing the Clinical Protocol
- Effectively Writing the Clinical Study Report
- Writing the NDA
- Regulatory Affairs 101: Regulations of Drugs and Biologics
One Day Seminars
- Regulatory Intelligence
- FDA Meetings 101 and How to Interact with the FDA
- Effectively Writing the Investigator’s Brochure
- Performing the Gap Analysis
- Writing the IND: Clinical Documents
- Writing the IND: Nonclinical Documents
- Writing the NDA: Clinical Documents (2.5 and 2.7)
- Writing the NDA: Nonclinical Documents (2.4 and 2.6)
- Writing the Global IND Application: EU
- Writing the Global IND Application: Canada
- Writing the Global IND Application: India
- Writing the Global IND Application: South America
- Writing the Global IND Application: Japan
- Writing the Global IND Application: China
- Writing the Global IND Application: Australia
- Writing the Global Orphan Drug Designation Application
- Regulatory Writing Tips and Techniques
- Regulatory Strategy: What is it and How to Do it
- Literature Review Basics
- RA Director: What is expected of you and what you need to know
- RA Manager: What is expected of you and what you need to know
- SOP Writing and SOPs needed for Regulatory Affairs
- Publication Planning
- Global Clinical Trial Registry Requirements: Posting and Maintenance
- Global Accelerated Approval Mechanisms Strategy and Application Content
Courses are comprehensive, insightful, highly interactive and provide information that can be applied immediately on the job. Case studies are frequently used to engage adult learners.
All one day courses can be extended to provide additional in depth practicum and exercises.
Custom courses can be developed or any of the above courses modified upon request. Please e-mail ask@regulatorium.com for more information.