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 “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.

We need the below information to serve you better

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).


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.
Register Online

Register Online

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

  • 2 Attendees
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-1-888-771-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "Regulatory Affairs in the USA (FDA) for Drugs and Biologics: 2-day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @


Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: or call us: +1-888-717-2436.

Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.


If you wish to sponsor this event please contact Ben Hobbs: or call us: (650) 620-2941

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.

Sea Creatures at Birch Aquarium
Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.

Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.

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.
Balboa Park
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.

La Jolla
In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
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.

Coronado Island
Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.