*This Primer Course requires an additional registration fee. You do not need to be registered for the Forum to attend*
This full-day in-person Primer is designed to meet the needs of individuals who are either new to biopharmaceutical-based regulated document management, information management, and regulatory submission publishing for authorities or already experienced in one area looking to gain a broader understanding. This Primer will present the full spectrum of the regulatory submission, information, and document management arena. Understanding the various steps throughout the life of document components from their authoring, publishing to PDF, assembling into a submission, delivery to regulatory agencies, and ultimately company archival will yield “aha” moments for the attendees of this offering from all functions along the life-span of regulatory content. “Ice breakers” will motivate and the “Hands-On” exercises will provide the attendees the ability to apply material as the day progresses.
Receive $150 off your forum registration by registering for any combination of at least two short courses and/or primers as well as the main forum. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.
Upon completing this course, attendees will be able to:
- Describe the benefits of understanding the complete life phases of regulatory content and the impact that decisions in one place along the life path will have at other stages of the process
- Identify key drivers within each of the life phases and potential pros and cons associated with solution choices
- Recognize the needs of the other organizations involved within the life span of the regulatory content and fairly assess their concerns in process and procedure decision making
- Comprehend the newly released regulations, guidelines, and industry best practices and gain an awareness of their impact
Regulatory Submissions, Information, and Document Management Forum
Preconference Short Courses
Short Course: The Future of Documents: Deep-Dive into Structured Content
Short Course: On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems