Overview of FDA Regulation of Medical Products: Drug, Device, Biologic or Combination (One and a Half-day In-person Seminar)
Mark Elengold, President, FDA Strategies LLC
Coming soon.. Please contact customer care for new schedule
The Food and Drug Administration (FDA) regulates medical products under several Federal laws, a myriad of regulations and many organizational units. The Federal Food, Drug and Cosmetic Act is a criminal statute that subjects the most senior corporate officials to liability under the “Park Doctrine”, even if they were unaware of the existence of their company’s problems.
What a medical product is considered to be by FDA can be the single most important the decision the Agency can make. How it will be regulated under the Federal Food, Drug, Cosmetic or Public Health Service Acts will determine the path (and speed) to market, what submissions will be required, and requirements after clearance or approval.
This seminar will discuss how product jurisdiction is determined by FDA under laws, regulations, guidance and even traditions. Various definitions and precedents will be discussed. Actual and hypothetical case studies in large group and workshop format settings will provide the critical thinking skills needed to understand the regulatory environment.
After an overview of the statutes and regulations for drugs, devices, biologics and combinations are discussed, three major subjects will be covered;
- Clinical trials and pre market approvals
- Current Good Manufacturing Practices/Quality System Regulation (cGMP/QSR)
- Post marketing requirements. Techniques and sources to remain current will be provided
- The statutory and regulatory framework for FDA regulation of medical products, including FDA's organization
- The path to market for drugs, devices, biologics and combination products, including generics and biosimilars
- Clinical trials and bioresearch monitoring (BiMo)
- The impact of user fees - old ones such as PDUFA and MDUFA, and new ones, such as GDUFA and BSUFA
- FDA inspection and compliance policies and procedures for medical products
- Manufacturing practices and quality regulation - cGMPs and QSR
- Considerations and requirements after a product is marketed
- Sources for FDA regulatory information
Who will Benefit:
Senior Management, staff new to an environment regulated by FDA, and those in industries allied to medical products, including:
- Corporate, Division and Site Executives and Managers
- Regulatory Affairs
- Medical Affairs
- Legal Staff
- Quality and Audit Personnel
- Investment Professions Covering Medical Products
- ANYONE with a need for an overview of the FDA Regulation of Medical Products
- FDA Regulation of Medical Products
- The statutory and regulatory framework
- Drugs, Devices, Biologics and Combination Products
- The Federal Food, Drug Cosmetic Act
- The Public Health Service Act
- FDA Organization
- Other FDA components including the Offices of Regulatory Affairs and Combination Products
- Paths to Market
- User Fees
- Workshop – Case Studies
- Clinical Data and Bioresearch Monitoring
- Patient Protection
- Good Clinical Practices
- Good Laboratory Practices
- The FDA Bioresearch Monitoring Program
- Current Good Manufacturing Practices/Quality System Regulation
- GMP/QSR Evolution – “No Margin for Error”
- GMPs for the 21st Century/Quality System Approach
- Workshop – Case Studies
- Inspections, Compliance, Enforcement
- Inspection Policies and Procedures
- Preparing for an Inspection
- Inspection follow-up
- Compliance Policies and Procedures
- Enforcement Policies and Procedures including management criminal liability under the “Park Doctrine”.
- Post Marketing Requirements
- Labeling, Advertising, Promotion
- Keeping Current
- The FDA Web Site
- Other Information Sources and Apps
Meet Your Instructor
President, FDA Strategies LLC
Mark A. Elengold is President of FDA Strategies LLC, which provides consulting services to FDA regulated industry and the financial community. He retired as the Deputy Director of the FDA’s Center for Biologics Evaluation and Research, after thirty-four years of service. He is an expert and frequent speaker on regulatory and compliance activities, Good Manufacturing Practices (GMPs), and FDA application review procedures, including electronic submissions.
After receiving a B.A. from Queens College of the City University of New York in 1971, he served as an FDA investigator in the New York District Office and the White Plains Resident Post. Prior to joining CBER in December, 1988, he held various positions in the Center for Drug Evaluation and Research, the Bureau of Veterinary Medicine and the Office of the Commissioner.
Register by P.O. / Check
Yes, I want to attend "Overview of FDA Regulation of Medical Products: Drug, Device, Biologic or Combination (One and a Half-day In-person Seminar)".
Click here to download P.O. 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
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.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
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 @ +1-888-717-2436 or email us @ firstname.lastname@example.org
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 ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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 ComplianceOnline 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 ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
If you wish to partner with us for this event
contact us: email@example.com
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
contact Cruise Webster: firstname.lastname@example.org
call us: (207) 576-4173
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.