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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
Coming soon.. Please contact customer care for new schedule

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) 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
  • Generics
  • 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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Venue

Location :

Special Offer for the attendees of this seminar:

Rooms available at only $179 per night.

Please note: Hotel rooms are limited and based on availability




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How to Reach

General Driving Directions:

Driving Directions from Chicago O'Hare International Airport – ORD: 16 mile(s) NW
  • Take I-190 East to I-90 (Kennedy Expressway) East to the Ohio Street Exit. Ohio Street is a one-way street eastbound.
  • Take Ohio to State.
  • Turn right on State, and go to Hubbard (3rd light).
  • Turn left and hotel entrance is on the left.

From Chicago Midway International Airport - MDW : 10 mile(s) SW
  • Take Cicero Avenue north to I-55 North
  • Take I-90/94 west into downtown
  • Exit Ohio St (one-way eastbound)
  • Make a right on State and hotel is on the corner of State & Hubbard.

Other Transportation:

Bus Station
  • Greyhound Bus Lines: 1.8 mile(s) SW

Subway Station
  • Red Line (Grand Ave): 0.2 mile(s) N

Train Station
  • Union Station (Amtrak & Metra): 1.7 mile(s) SW

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

One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.




The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.

Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!




With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.




You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.




A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.

Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.





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