Regulatory Strategy 101

Drug development is getting more expensive by the year and a sound regulatory strategy can make or break a drug or biologic’s ability to initiate and support clinical trials or obtain marketing approval. Knowing what to research, review, negotiate and include in the regulatory strategy differs by company; however, basic requirements include:

• Target product profile/draft package insert
• Past precedence review
• Clinical endpoints
• Competitor label analysis
• FDA interactions planning

As a regulatory professional develops their skill set, knowing how to create and implement a regulatory strategy is critical to career advancement. This session will walk participants through a case study for a hypothetical Type 2 Diabetes drug that has just been developed and the process of creating a regulatory strategy. The session will:

• Define regulatory strategy
• Provide an overview of regulatory strategy elements, by phase of development and discipline

• Illustrate how to research and pull together a strategy
• Planning regulatory strategy in Phase 1, Phase 2 and Phase 3
• How to adapt and update a strategy as information changes

Participants will walk away with a strategy toolbox they can immediately apply to their jobs.   

• Identify the elements of regulatory strategy
• Understand the questions that need to be addressed when developing a regulatory strategy,by phase and discipline
• Locate and use available tools that can aid in developing regulatory strategy
• Summarize the data and perform strategic analysis once the data is identified
• Determine the output and format of strategic information after analysis into a “playbook”

• Mid-level regulatory professionals who have 3-5 years regulatory experience and are looking to learn the “next level” of regulatory, beyond submission preparation
• Any other drug development team member that would like to learn more about regulatory strategy

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.

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Day 1: 8:30a.m. – 5:00 p.m.

• What is regulatory strategy? 
• What makes good strategic qualities? 
• How to perform strategic analysis 
• Component of strategic analysis
  • Questions to be answered by discipline and phase 
  • The tools to answer questions (free and for fee)
    • History of indication 
    • Clinical endpoints 
    • Past precedence 
    • Planning FDA interactions 
     
  • Summarizing the information 
  • Analysis 
  • Format and output examples 
  • Presentation to the team (let format follow information)
   
• Land mines (how to plan for them or mitigate as much risk as possible)
• Updates and monitoring the regulatroy landscape
• Performing strategy at different phases of investigation and how it differs

• Using a mock indication and regulatory intelligence tools, research sections of the regulatory strategy
• How to use templates to summarize components of the strategy
• How to formalize regulatory’s portion of the strategy into a “playbook"

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-13-048-L01-P. Released 9/13.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.