Regulatory Affairs in the USA (FDA) for Drugs and Biologics: 2-day In-Person Seminar

Course Description:

This regulatory compliance training will give the participants a detailed presentation on regulatory affairs of human pharmaceuticals (drugs and biologics) in the United States to work with the Food and Drug Administration (FDA).

This 2-day interactive course on FDA regulatory affairs includes FDA submissions; INDs, NDAs, BLAs, aNDAs, biosimilars and post-approval submissions. Each item of these submissions will be presented, analyzed, and discussed in conjunction with relation to FDA regulations, guidance’s, and precedents. It will also cover some international aspects of regulatory affairs with regards to FDA’s adherence to International Conference on Harmonization (ICH) guidance.

In addition to FDA submissions, this course on regulatory affairs will also include:

• Interactions, and meetings with the FDA
• Technical aspects of regulatory affairs
• Chemistry Manufacturing and Controls (CMC/GMP)
• Nonclinical (animal safety studies, GLP)
• Clinical (human clinical studies, GCP)
• Submission styles of the Common Technical Document (CTD) formatting
• Electronic submissions (eCTD)

Learning Objectives:

• History/evolution of the FDA
• How to develop strategies for drug development with FDA
• Requirements for obtaining clearance to start clinical trials via an Investigational New Drug (IND)
• How to contact and request meetings with FDA
• Non-clinical (animal safety studies) for clinical phase and marketing applications
• Clinical (human clinical trials) for clinical phase and marketing applications
• Chemistry manufacturing and controls (CMC) for clinical phase and marketing applications
• How to compile, publish, and submit a IND, NDA, BLA, aNDA, and Biosimilars
• Electronic submissions
• Acts, Directives, Regulations, Guidances, and Precedents
• FDA regulatory fees
• How and why FDA has different requirements for drugs vs. biologics
• Regulatory expectations during each stage of drug development
• What a regulatory person should know about GMPs, GLPs, and GCPs
• FDA regulatory enforcement
• FDA’s accelerated regulatory review processes
  • Fast Track
  • Priority Review
  • Orphan Drug Status
  • Accelerated Approval
  • Breakthrough Therapies
  • Therapies to Combat Bioterrorism
• How FDA reviews your application
• Generics (including biosimilars)
• Post marketing commitments
• Various FDA specific topics: Drug Master Files (DMF), advertising basics, naming drugs, Freedom of Information Act, National Drug Code Number (NDC number), PDUFA, GDUFA, FDAsia, Special Protocol Assessments, dispute resolution, and more.

Who Will Benefit:

The course will benefit the participants from the following categories:

• Regulatory affairs professionals
• Quality and manufacturing professionals
• Clinical development professionals
• Regulatory authorities
• Business and marketing professionals
• People investing in FDA-regulated product development projects