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
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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.
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Boston Park Plaza Hotel & Towers
50 Park Plaza at Arlington Street,
Boston, MA 02116
March 5-6, 2013
How to Reach
From the West:
Take the Massachusetts Turnpike (Rte. 90 East) into the city. Exit at Copley Square (22) and follow straight onto Stuart St. Follow to the 5th set of lights and turn left for the Boston Park Plaza Hotel.
From the North:
Take Route I-93 South into Boston. Take the Storrow Drive - Exit 26 off of I-93. Follow Storrow Drive and exit left at the Back Bay/Copley Exit. At lights, take left onto Beacon St, and then take an immediate right onto Arlington St. The Boston Park Plaza Hotel is the 2nd building on the left after the park.
From the South:
Follow I-93 North towards Boston. Take the Storrow Drive - Exit 26 off of I-93. Follow Storrow Drive and exit left at the Back Bay/Copley Exit. At lights, take left onto Beacon St., and then take an immediate right onto Arlington St. The Boston Park Plaza Hotel is the 2nd building on the left after the park.
From Logan Airport:
Follow signs to Sumner Tunnel/Boston. Take the ramp onto RT-1A S/William F McClellan Hwy. Merge north onto Interstate 93 and take the Storrow Drive - Exit 26. Follow Storrow Drive and exit left at Back Bay/Copley Exit. At lights, take left onto Beacon St, and then take an immediate right onto Arlington St. The Boston Park Plaza Hotel is the 2nd building on the left after the park.
From Logan Airport - You have 3 options when arriving at Logan International Airport:
- Airport Cab Service (meter rate)
- Boston 's Subway: The "T"- The Boston Park Plaza Hotel is located on Arlington Stop (Green Line) and Back Bay Stop (Orange Line)
- Ultimate Shuttle
24-hour Taxi Service available at the Hotel's Main Entrance.
T Service - Subway:
The Hotel is 1 block from the Arlington T Stop off of the Green Line and 3 blocks from the Back Bay T Stop off of the Orange line.
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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.