Course Description

Enhance your regulatory affairs skills and advance your career with our comprehensive training program designed for both new and experienced regulatory professionals in the pharmaceutical and device industries.

Your regulatory department serves as the key contact with regulatory agencies. Individuals within the regulatory department prepare development plans and documents, maintain Agency communications, address inquiries, schedule meetings, construct marketing applications and submit updates in a concise and informative manner. Agency submissions require strategy, editing, publishing and information tracking. During drug and device development, a key step is to begin one or more clinical trials and each trial typically requires an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application negotiated with the FDA prior to study start.

This course combines lectures, case studies, and exercises to teach new and experienced regulatory professionals how to navigate the regulations, interpret the guidance documents, and how to use a style guide when writing technical documents like the IND or IDE. The goal for this training to support fully compliant and clear submissions and to avoid as many questions as possible during the IND/IDE process.

The ability to construct drug labels and approval summaries will be discussed as part of the IND/IDE process. Learners will also gain experience developing timeline management tools and coordinating contributor submissions for each of the IND/IDE sections.

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 regulations and guidance documents for drug and biologic IND/IDE submissions
• Use regulations and guidance documents to outline and construct IND/IDE submissions
• Apply style guides for IND/IDE writing, editing, publishing, and information tracking to ensure regulatory compliance
• Use timeline management tools and coordination techniques to manage team contributions to IND/IDE sections

Course Outline

• Module 1: FDA Information, IND/IDE regulations and guidance documents
• Module 2: IND/IDE Elements (outline, documents and details)
• Module 3: Common Technical Document Format
• Module 4: Pre-submission meetings about Pre-Market IND/IDE Applications
• Module 5: Reporting requirements during an IND/IDE
• Module 6: When to update IND/IDE elements and tracking each IND submission

Who Should Attend

• Any Member of the Drug Development Team who wishes to know more about the IND/IDE 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.