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

By:Ronald H. Carlson, Regulatory Affairs and Quality Consultant, Carlson Consulting
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Course “Regulatory Affairs in the USA (FDA) for Drugs and Biologics” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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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

Course Outline:

Day One (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
Day One (8:30 AM – 4:30 PM)
  • 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
  • Generics
  • Post approval submissions
  • Other regulatory topics

Meet Your Instructor

Ronald Carlson
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).

Venue

Location 1:
Double Tree San Diego Downtown,
1646 Front Street,San Diego,
California, 92101,USA

February 27-28, 2014
Special Offer for the attendees of this seminar:
Rooms available at only $129 per night.
Call Hotel and identify yourself as part of the ComplianceOnline Group
Please note: Hotel rooms are limited and based on availability


How to Reach

From San Diego International Airport / Lindbergh Field, CA: 2.6 miles

  • Depart from San Diego International Airport / Lindbergh Field, CA (0.1 mi.)
  • Keep left toward N Harbor Dr (0.4 mi.)
  • Turn left onto N Harbor Dr (1.4 mi.)
  • Turn left onto W Grape St (0.3 mi.)
  • Turn right onto Columbia St (0.2 mi.)
  • Turn left onto W Date St (0.1 mi.)
  • Turn right onto Union St (0.0 mi.)
  • Arrive at Union St on the left (0.0 mi.)
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
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Local Attractions

San Diego Cabrillo National Monument
The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.

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San Diego Zoo Safari Park
The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.
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La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.

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