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Introduction to Biotechnology Law
and Regulation

A Program Focusing on Human Biologicals and Drugs


June 5-6, 2008

The Embassy Suites Washington, D.C. Convention Center Hotel

Register Today!

Conference Registration Policy

  • General Information
  • Agenda
  • Hotel Information


Speakers
David G. Adams, Chairman, FDA Group, Venable, LLP
Donald O. Beers, Partner, Arnold & Porter LLP
Benjamin L. England, Attorney and Founder, FDA Imports
Jeffrey K. Francer, Assistant General Counsel, PhRMA
Edward L. Korwek, Ph.D., Partner, Hogan & Hartson, L.L.P.
Natasha V. Leskovsek, Partner, Heller Ehrman LLP
Dawn Shawger McCord, Attorney at Law, Sedgwick Detert Moran & Arnold LLP
Deborah M. Shelton, Special Counsel, Sheppard, Mulllin, Richter & Hampton, LLP

Program Description
This year's program has been updated to include the latest requirements, as well as key changes to pre-existing regulations, imposed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). New this year is a section on the clinical trial database and postmarket safety. Also, there will be a discussion on follow-on biologicals. You will learn the organizational structure of FDA and obtain an overview of its regulatory process with regard to human biotechnology products, including biologicals, drugs and tissue. This is a program that will provide you with the basics of FDA regulation pertaining to the development, manufacturing, marketing and post-marketing requirements of biotechnology products including human biologicals and drugs. You will become more familiar with many of the acronyms used in the biotechnology arena, such as VAERS, GLPs, GMPs, IND, NDA, ANDA, BLA and others. Topics will also include section 505(b)(2) application regulations, as well as those related to expedited, fast track, and accelerated approval; responding to violations reported by FDA; advertising and promotion; import/export requirements and market exclusivity. 

The program will also help you comply with FDA’s regulations, and identify and address potential areas for regulatory problems. You will also acquire a basic overview of other administrative agencies involved with the regulation of human biotechnology products, and the framework of requirements they enforce.  The program will enable you to get answers to your questions through lively audience participation. 

Who Should Attend?
You should attend this program if you’re in regulatory affairs, from the legal community, or from a federal or state regulatory agency and need an overview on biotechnology law and regulation.  The interactive nature of this workshop requires that attendance be limited.  Early registration is recommended.  This workshop will be held in an informal, classroom atmosphere where dialogue and questions will be encouraged.  FDLI suggests that attendees dress comfortably in “casual business attire.”

Handout Materials
A binder containing speaker presentations and handouts.

FDLI’s 2008 Statutory Supplement: Federal Food, Drug, and Cosmetic Act and Related Sections of Additional Statutes.

Registration Fees
Early Bird Rate (Received before Friday, May 2, 2008):
$ 895 Member
$1,320 Non-member
$720 Gov't/Academic/Non-Profit

Regular Rate (Received after Friday, May 2, 2008):
$ 995 Member
$1,395 Non-member
$795 Gov't/Academic/Non-Profit

Special CD Price!
Purchase the CD set for just $99 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, D.C. addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.

JUNE 5
 
8:00 a.m.
Registration and Continental Breakfast
 
8:30 a.m.                     
FDLI Welcome and Announcements
 
I. Origins and Organizational Structure of FDA and Overview of the Regulation
of Biological Products
  A.Landmark Legislative Enactments for Biologics Regulation and Development
of Today’s Statutory Framework
   
  • The Pure Food and Drugs Act of 1906 and Section 351 of the Public Health Service Act (PHSA) and Beyond – The Evolution and History of Human Biologicals/Drugs Regulation
  • Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
  • The Food and Drug Administration Modernization Act of 1997 (FDAMA): Changes to Regulation of Biologicals/Drugs
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BTA)
  • Project Bioshield Act of 2004
  • Medicare Modernization Act of 2003 (MMA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  B. Food and Drug Administration
   
  • History
  • FDA’s Dual Mission -- The Dilemma
  • The Food and Drug Administration Act of 1988
  • FDA’s Place in Government
  • Responsibilities and Structure of Headquarters and the Field
  • Establishment License Application (ELA) to Biologics License Application (BLA) Transition (See 601.2 for listing and FR 147:40858, 1998)
  • CBER/CDER Consolidation – Therapeutic Biological Products (TBPs)
  • Specific Areas of Overlap between Drugs and Biologicals
  C. Relevant Functions of Other Entities
   
  • U.S. Department of Health and Human (HHS)
    Services
  • Federal Trade Commission (FTC)
  • U.S. Department of Justice (DOJ)
  • The Securities and Exchange Commission (SEC)
  • U.S. Department of Veterans Affairs
  • U.S. Department of Homeland Security (DHS)
  • The States; State Attorneys General
  • Congressional Budget Office (CBO)
  • Environmental Protection Agency (EPA)
  • U.S. Department of Agriculture (USDA)
 
II. FDA’s Regulatory Processes
  A. Sources of Legal and Regulatory Requirements and FDA Policies
   
  • Statutes; FDCA
  • Regulations
  • Federal Register (FR) Notices
  • Advisory Opinions and Preambles
  • Guidance Documents; Good Guidance Policy (GGP)
  • Compliance Policy Guides (CPGs)
  • Staff Manuals, Guides, and Programs
  • Miscellaneous Publications
  • Enforcement Actions and Letters                                  
  • Citizen Petition Responses
  • Informal Statements and Advice
  B. Non-FDA/External Requirements and Pronouncements/ Standards
   
  • International Conference on Harmonization (ICH)
  • United States Pharmacopeia  (USP)
  C. Participating in FDA Policymaking
   
  • Citizen Petitions
  • Rulemaking Comments and Hearings
  • Judicial Review
  D. Product Specific Regulatory Proceedings
   
  • Informal Adjudications
  • Regulatory Hearings
  • Formal Adjudications
  • Judicial Review
  E. Obtaining and Protecting Information under the Freedom
of Information Act (FOIA)
   
  • Mandatory Disclosures on Request
  • Discretionary Disclosure on Request                
  • Preventing Disclosure of Information Submitted to FDA
 
Refreshment Break
III. FDA Review and Approval Requirements
  A. Definition of Biological, Drug
   
  • The Key Principle – Intended Use
  • Statutory Definition
  B. Biological/Drug Regulation
   
  • Effectiveness – Substantial Evidence (SE)
  • Adequate and Well Controlled Studies
  • Safety – Balancing Risk and Benefit
  • Safe, Pure, and Potent; Biological Standards
  • Biologicals/Drugs for Serious or Life-Threatening Illnesses
  C. Routes for New Biological Approval
   
  • FDCA-Approved Biologicals
  • PHSA-Approved Biologicals (Section 351)
  D. Human Cellular and Tissue Regulation
   
  • Good Tissue Practices (GTPs)
  • Somatic Cell Therapy Policy
  E. Combination Products and Other Products
   
  • Office of Combination Products
  • CDER, CBER, and CDRH Intercenter Agreements
  • Primary Mode of Action (PMOA)
 
11:50 a.m.- 12:50 p.m.
Lunch
 
12:50 p.m.                   
IV. Regulation of Biological/Drug Development
  A. Preclinical Testing/Investigation
   
  • Good Laboratory Practices (GLPs) Regulations
  B. Clinical Testing/Investigation and Good Clinical Practice (GCPs)
   
  • Investigational New Drug (IND) Applications                                                               
  • Phase I, Phase II, Phase III
  • Role of the Protocol
  • Informed Consent
  • Institutional Review Boards (IRBs)
  • Obligations of Sponsors and Investigators
  • Office of Human Risk Protection (OHRP)
  • Clinical Hold
  • Promotion of Investigational Drugs
  • SEC/FDA Interactions
  C. Treatment INDs and Emergency Use
D. Fast Track Review/Accelerated (Conditional) Approval
V.      The BLA and Full NDA
  A. Content and Organization
   
  • Safety and Effectiveness Data
  • Manufacturing Facilities, Processes,
    and Controls
  • Packaging
  • Proposed Labeling
  • Patent Information
  • Biological and Drug Master Files (BMFs, DMFs)
  • Debarment Certification
  • Clinical Trial Databank Compliance Certification
  B. The Review Process
   
  • User Fees
  • The Review Clock and the Impact of  PDUFA                                     
  • Interacting with FDA
  C. Examples of BLA Approvals and Non-approvals
D. Responses to FDA Adverse Decisions
   
  • Right to a Hearing on Refusal to Approve an Application
  • Judicial Review of Refusal to Approve an Application
  • Judicial Review of Approval of a Competitor’s Application
  • Post-Approval (Phase IV) Investigations
 
Refreshment Break
VI. Clinical Trial Databank and Postmarket Safety Requirements under FDAAA
  A. ClinicalTrials.Gov Database
   
  • Clinical Trial Registry Requirements
  • Clinical Trial Results Requirements
  B. Post-Market Safety Requirements
   
  • Postmarket Studies and Clinical Trials
  • Risk Evaluation and Mitigation Strategies (REMs)
  • Active Post-Market Risk Identification and Analysis
  • Enforcement
VII. Patent and Non-Patent Exclusivity Issues
  A. PHSA-and FDCA-Approved Biologicals
   
  • Patent Term Extension (PTE)
  • Orphan Drug Exclusivity
  B. FDCA-Approved Biologicals
   
  • 505(b)(2s)
 
5:00 p.m.         
Adjournment
 
JUNE 6
 
8:00 a.m.                    
Continental Breakfast
       
8:30 a.m.                     
VIII.    Post-Approval Issues
  A. MedWatch, Vaccine Adverse Event Reporting System (VAERS)
B. Post Marketing Surveillance
   
  • Current Good Manufacturing Practices (cGMPs)
  • Departure from Compendial or Represented Standards
  • Insanitary Conditions
  C. Scope of Pre-Approval Inspections (PAIs)
   
  • Clinical data
  • Manufacturing
  • Packaging
  • GMP Compliance
  • Validation
  D. Inspections
   
  • Audit Process
  • Arranged in Advance
  • Usually Multi-day
  • Inspectional team
     
  • Team Biologics
   
  • Search Warrants
     
  • Administrative
  • Criminal
   
  • Procedure
  • Photographs and Recordings
  E. Responding to FDA Form 483 Observations
 
Refreshment Break
X.        Regulation of Biological Marketing
  A. Advertising and Promotional Labeling Branch, Office of Compliance and Biologics Quality (OCBQ), CBER, FDA and Division of Drug Marketing and Communications (DDMAC), Office of Medical Policy, CDER, FDA
B. Intended Use
C. Misbranding                                                
   
  • Label and Labeling Defined
  • False or Misleading Labeling
  • Material Omissions
  • Lack of Adequate Directions or Warnings
  • Absence of Label Statements of Identity, Source, Ingredients,
    or Quantity
  • Danger to Health when Used According to Labeling
  D. Promotion and Advertising
   
  • Promotional Labeling
  • Advertisements
  • Current Issues
  • FDA Informal Enforcement Techniques
       
12:15-1:30 p.m.          
Lunch
       
1:30 p.m.                    
XI. Import and Export Requirements and International Issues
  A. Imports
   
  • Importation from Foreign Sources; Canada
  • Import for Export
  • Import Detentions and Refusals
  • Bovine Spongiform Encephalopathy (BSE) Issues; Product Sourcing
  B. Exports
   
  • Exporting Unapproved Biologicals and Vaccines
  • FDA's Recent (November 23, 2005) Final Rule Implementing the Export Reform & Enhancement Act
  C. International Harmonization
D. Counterfeit Biologicals/Drugs
E. Role of U.S. Department of Homeland Security (DHS)/Customs and Border Protection (CBP)
F. Biologicals and Vaccines for Emergency Use                                                
XII. New, Emerging, and Continually Interesting Issues
       
Refreshment Break
     
XIII. Violations and Enforcement
  A. The Interstate Commerce Element
B. Prohibited Acts
C. Enforcement Tools and Procedures
   
  • Warning Letters (WLs) and Untitled Letters
  • Use of Media/Publicity
  • “Voluntary” Recalls
  • Civil Penalties/Disgorgement
  • Seizure Actions
  • Suits for Injunctions, Consent Decrees
  • Criminal Prosecutions
  D. Field Alert Reports ((FARs) for FDCA-approved products)
E. Biological Product Deviation Reports ((BPDRs) for PHSA-approved products)
   
  • Biologic Comparability Protocols
  • Production and Process Controls
  • Standard Operating Procedures (SOPs)
       

4:30 p.m.         
Adjournment
     

 

Meeting Date(s) June 5-6, 2008

Hotel Reservations
The Embassy Suites Washington, D.C. Convention Center Hotel
900 Tenth Street, NW
Washington, D.C.  20001
202-739-2001 phone
202-739-2099 fax
Web: The Embassy Suites Washington, D.C. Convention Center Hotel

Room Rate
$209 single, $239 double + applicable taxes.
Identify yourself as being with the Food and Drug Law Institute or FDLI.

Reservation Cut-Off May 9, 2008

Check-in 4pm
Check-out 12pm

Valet Parking
$26 per day
*Rates subject to change without notice.

Directions
From the Metro:
Take the Blue, Orange or Red line to Metro Center. Follow signs for the 11th Street and G Street exits. Make a right onto 11th Street, and head north for 3 blocks. Make a right onto New York Avenue, then a left onto 10th Street NW. The hotel is on the left, in between New York Avenue and K Street, NW, located on 10th Street, NW.

More Directions [provided by the Hotel's web site]