9-Hour Regulatory Strategy Development

Course Description

The cost of drug and device development is getting more expensive, underscoring the importance of a sound regulatory strategy. Such a strategy can determine if a drug, device or biologic has the ability to initiate and support a clinical trial 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 program will walk learners through a case study focusing on a newly developed product and the step-by-step process of creating a regulatory strategy. In this session, you will learn:

• The definition of regulatory strategy
• Regulatory strategy elements, by phase of development and discipline
• How to research and pull together a strategy
• How to plan and modify the regulatory strategy in Phase 1, Phase 2 and Phase 3
• Ways to adapt and update a strategy as information changes

Participants will walk away with a strategy toolbox that can be immediately applied on the job.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• 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”

Course Outline

• Module 1: What is regulatory strategy?
• Module 2: What makes good strategic qualities?
• Module 3: How to perform strategic analysis
• Module 4: Landmines (how to plan for them or mitigate as much risk as possible)
• Module 5: Updates and monitoring the regulatory landscape
• Module 6: Performing strategy at different phases of investigation and how it differs

Available by individual module! Contact Barnett to learn more.

Who Should Attend

• Mid-Level Regulatory Professionals who have 3-5 years of regulatory experience and are looking to learn the “next level” of regulatory, beyond submission preparation
• Drug Development Team Members that would like to learn more about regulatory strategy

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

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

Click here for complete trainer biographies

Course Length and Time

1.5 hours/week for 6 weeks.

Registration Fees

$1,595 by Early Bird Deadline 

$1,795 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 9 hours (0.9 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-065-L99-P. Released: 8/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.