Course Description

The Regulatory Department is the key contact with regulatory agencies. Regulatory must prepare documents that inform the Agency about the proposed development plan, keep the Agency up-to-date and answer any questions the Agency has about an on-going investigation, request and prepare for meetings with the Agency to discuss development plans, construct and write the marketing application and submit any updates to the marketing application in a concise and informative manner.

Submissions to a regulatory agency involves more than just writing. It entails strategy, editing, publishing and systematic tracking of key information. Through a blend of lectures, case studies, and hands-on exercises new and experienced regulatory professionals will learn how to navigate the regulations, guidance documents, and style guides to produce submissions that comply with the requirements and are clear to the reviewers.

Approved drug labels and summary basis of approvals are also used to help learners acquire the knowledge and insight needed to understand and construct core U.S. drug and biologics submissions, including pre-marketing (IND), and marketing (NDA/CTD) applications. In addition, learners will gain experience using tools that help manage timelines and sections needed from contributors.

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 required regulations and guidance documents for drug and biologic submissions
• Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions
• Formulate a working knowledge of regulatory submissions, publishing, and style guides
• Create checklists that encompass timelines and sections needed from contributors

Course Outline

• Module 1: FDA Division Information
• Module 2: Publishing the Submission
• Module 3: Tracking the Submissions
• Module 4: Common Technical Document Format
• Module 5: Pre-Market
• Module 6: Marketing Application

Who Should Attend

• Any Member of the Drug Development Team who wishes to know more about the IND submission and amendment process
• Regulatory Associates
• Quality Assurance, Manufacturing, Clinical, Project Management, and Pre-Clinical Personnel

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#: 0778-0000-24-066-L99-P. Released: 10/24.

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