Regulatory Affairs in the USA (FDA) for Drugs and Biologics
Ronald H. Carlson, Regulatory Affairs and Quality Consultant, Carlson Consulting
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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)
- 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
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Basis for FDA’s authority to regulate drugs and biologics
- Regulations, guidelines and precedents for the drug development process
- FDA regulatory drug development process and strategic considerations
- Contacting FDA
- FDA meetings
- FDA requirements and expectations during the drug approval process
- FDA pre-IND meeting
- FDA end of phase 2 meeting
- FDA pre-NDA/BLA meeting
- Preparation of the NDA/BLA/aNDA submission
- Review of the Common Technical Document (CTD) format and electronic submissions (eCTD)
- What happens after the marketing dossier is submitted
- Post approval submissions
- Other regulatory topics
Meet Your Instructor
||Ronald H. Carlson
Regulatory Affairs and Quality Consultant, Carlson Consulting
Ronald H. Carlson Ph.D. has more than 25 years of pharmaceutical industry experience in Regulatory Affairs and Quality. His experience is in the areas of both drugs and biologics in both small and large companies. While he was Vice President of Regulatory Affairs and Quality at InSite Vision, Mr. Carlson had overall responsibility for the NDA approval of AzaSite. He has contributed to the CMC section of several BLAs (Activase, Raptiva, Actimmune, and Pulmozyme). He has experience with all phases of drug development covering more than 10 INDs as well as regulatory strategy. His background is as a generalist thus has regulatory expertise in clinical, non-clinical, CMC, and regulatory operations (including eCTD). He has interfaced with FDA on regulatory submissions as well as audits (GMP, GCP, and GLP).
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