Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.
In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.
Learning Objectives:
- Identify the required regulations and guidance documents for drug and device submissions
- Use regulations and guidance documents to outline and construct drug and device submissions
- Formulate a working knowledge of regulatory submissions, publishing, and style guides
- Create checklists that encompass timelines and sections needed from contributors
Areas Covered:
- Contents of IND and IDE
- Regulatory requirements for IND and IDE application process
- Submissions to IND or IDE to the FDA
- Establishing communications with FDA
- Type of FDA meetings
- Amendments to IND and IDE applications
- Progress reports for IND and IDE
Who will Benefit:
- Project Managers
- Clinical Research Associates
- Data Managers
- Project Team Leaders with limited direct regulatory experience
- Grant Administrators
- Regulatory Associates
- Quality Assurance specialists
- Manufacturing, Clinical, and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process
- 8:30 AM - 8:59 AM: Registration. Meet & Greet.
- 9:00 AM - 11:00 AM:
FDA Division Information. Overview of Submissions Process and Assembling Application: creating the Table of Contents, timing of submission/timelines, contributions from other departments, editing, style guides, templates, supportive documents, QA for the submission. - 11:00 AM - 12:00 Noon:
Overview of Investigational Drug Application (IND) format and contents. - 12:00 Noon - 1:00 PM: Lunch.
- 1:00 PM - 2:30 PM:
Preparation for IND Submission. Routine IND Submissions: Assembling clinical, non-Clinical, CMC, etc. data for FDA drug applications.- Tracking the Submissions: Creating the index history an issues log.
- 2:30 PM - 3:00 PM: Refreshments Break.
- 3:00 PM - 4:30 PM: Preparation for meetings with FDA.
- Types of FDA Meetings: Type A, B and C;
- Pre-IND, Phase I, Phase II, End of Phase II, requesting the meeting, preparing the meeting package, meeting minutes.
- 8:30 AM - 8:59 AM: Registration, Meet & Greet.
- 9:00 AM - 11:00 AM:
- IND Maintenance: Annual Reports, Safety Reports and Investigator Brochure updates, protocol and informational amendments, Investigator change notifications.
- Special situations for IND submissions: Fast track, orphan drug designation, special protocol assessment.
- 11:00 AM - 12:00 Noon:
Overview of device classes, significant and non-significant risk determinations. - 12:00 Noon - 1:00 PM: Lunch.
- 1:00 PM - 2:00 PM:
- Investigational Device Exemption (IDE) content and application process, regulatory requirements and best practices.
- Strategies for new device application submissions with FDA depending on the class of the device.
- 2:00 PM - 2:30 PM:
IDE maintenance: supplements, amendments, safety and annual reports. Additional types of device studies: Extended access programs and Humanitarian Device Exemption (HUD). - 2:30 PM – 2:45 PM: Refreshments Break.
- 2:45 PM – 3:45 PM:
- Group work on the case study.
- Case Study: “Investigational New Drug Application Preparation”.
- 3:45 PM - 4:30 PM: Discussion of the Case study and Closing remarks
Peggy J. Berry
MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).
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The Franklin Institute
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