Upcoming

Public Meeting - Radioactive Drugs for Certain Research Uses
November 16, 2004, Rockville, MD. Meeting Information

FDA/ISPE Forum on New PAT Guidance, November 16, 2004, Arlington, VA (international locations also available) Meeting Information

Preparation for International Conference on Harmonization Meetings in Yokohama, Japan October 19, 2004, Rockville, MD.  Meeting Information

Past

2004 PDA/FDA Joint Regulatory Conference
DATE AND TIME: September 20-24, 2004, 8:30 am
LOCATION: Omni Shoreham Hotel, Washington, DC
CONTACT:  Deborah Stokes, PDA, 301-656-5900 ext. 129

Building on a tradition that began more than 14 years ago, PDA is partnering with FDA to host the 2004 PDA/FDA Joint Regulatory Conference in Washington, D.C.  The 2004 PDA/FDA conference will link pharmaceutical, biopharmaceutical and combination products associates, managers, directors and senior executives with the FDA officials driving the latest regulatory initiatives and industry experts who will provide the industry perspective on the ever-changing regulatory framework. The theme for the conference, The New Guidances, refers to the many targeted guidances resulting from FDA's overhaul of GMP and quality control oversight. Meeting information and registration.

DIA First Annual Leadership Conference for Clinical Research Professionals: The Future of Drug Development in a Cost-constrained Environment
DATE: September 20-24, 2004
LOCATION: Philadelphia, PA
Program Co-Chair: David G. Orloff, MD, Director, Division of Metabolic and Endocrine Drug Products, Center for Drug Evaluation and Research, FDA.
Program Information and Registration

Scientific Considerations Related to Developing Follow-On Protein Products
Date and Time: Tuesday, September 14, 8:30 am - 5:00 pm; Wednesday, September 15, 8:00 am - noon.
Location: University of Maryland -- Shady Grove Conference Center, 9630 Gudelsky Dr. Rockville, MD 20850
Meeting Information and Presentations

FDA/DIA Pharmacogenomics Workshop: Co-Development of Drug, Biological, and Device Products; The US Food and Drug Administration (FDA) is embarking on a new guidance initiative for the co-development of pharmacogenomic based therapeutic drugs or biological products and the diagnostic tests that are necessary for therapeutic decision making. In preparation for drafting this new guidance, the FDA and the Drug Information Association (DIA) have developed a one day workshop in collaboration with Pharmaceutical Research and Manufacturers of America (PHRMA), Biotechnology Industry Organization (BIO), Advanced Medical Technology Association (ADVAMed), Medical Device Manufacturers Association (MDMA), DIA Biotechnology SIAC, and the Pharmacogenomics Working Group (PWG) to identify the important issues in the co-development of pharmacogenomic combination products. It was deemed important by FDA to have this input from a public workshop before drafting guidance. In this context the diagnostic tests may include, but are not limited to, tests such as those used to determine whether patients should be treated, the dose used for treatment, or the risks associated with treatment. FDA expects to develop guidance for the co-development of therapeutic and diagnostic products where both will be necessary in the clinical management of patients. The workshop is to be held at  the Mariott Crystal Gateway Hotel (Arlington, VA) on July 29, 2004. Registration and additional information can be found at the DIA web site.

Public Meeting on Electronic Record; Electronic Signatures (Part 11), June 11, 2004, from 8 a.m. to 4:30 p.m., National Transportation Safety Board Conference Center, Washington, DC.  Meeting Information.

Drug Quality System: cGMP's for a New Era - 2004, (Co-sponsored by FDA and Consumer Healthcare Products Association), two dates and locations, Monday, July 12, 2004, Parsippany, NJ, and Monday, August 9, 2004, Chicago, IL. Meeting information and registration. Online Registration

Preparation for International Conference on Harmonization Meetings in Washington, D.C., Monday, May 17, 2004, Rockville, MD. Information.

AAPS 2004 National Biotechnology Conference, Co-Sponsored with FDA, May 17 - 19, 2004,  Boston, MA. Registration

FDA/NIH Joint Symposium on Diabetes: Targeting Safe and Effective Prevention and Treatment, May 13-14, 2004, Bethesda, MD. Information and Registration. Although there is no fee to attend this public meeting, pre-registration is required for those interested in attending.

Pregnancy Exposure Registries: Evaluating the Teratogenic Potential of Pharmaceutical Products Used at Clinical Doses, May 24-25, 2004, Washington, D.C. (Sponsored by the Drug Information Association)  Information and Registration

Public Meeting on Structured Products Labeling - Benefits and Challenges, Friday, June 4, 2004, College Park, MD.  Meeting Information

AAPS Workshop on Pharmacokenetics and Pharmacodynamics of Drugs in Pregnant and Lactating Women: Issues and Challenges, Co-Sponsored with  FDA, May 3-4, 2004, Arlington, VA. Information.

SoCRA FDA Clinical Trials Requirements and GCP Conference, Co-sponsored with FDA, April 21 and 22, 2004 in Livonia (DETROIT area), Michigan. Information and Registration;  Agenda

Creating New Knowledge: FDA & Industry in Dialogue - Tuesday, April 20, in Philadelphia, PA. The fifth annual conference between the FDA and Industry sponsored by Temple University School of Pharmacy. Keynote Speakers: Janet Woodcock, MD, Acting Deputy Commissioner for Operations, FDA; Steven Galson, MD, MPH, Acting Director, CDER; and Industry Leaders.  Agenda and Registration.

Electronic Common Technical Document Training Public Workshop, Thursday, February 26, 2004, Rockville, MD. Information and Registration

ISPE Briefing on the new FDA 21 CFR Part 11 Final Guidance – Electronic Records; Electronic Signatures. FDA co-sponsored live "webinar" November 13, 2003, repeated November 24, 2004. Information and registration.

Quality Systems and Regulatory Innovation for the 21st Century, November 19-21, 2003, Noordwijk aan Zee, The Netherlands (sponsored by the International Pharmaceutical Federation and supported by FDA) Conference Description and Registration.

Providing Quality Care: Examining the Clinical and Cost Effectiveness of Community Pharmacist Interventions,  December 5, 2003,  Arlington, VA. Information.

AAPS Workshop on Achieving Sterility: Future Direction in Aseptic Processing, Co-Sponsored with FDA and USP , December 8 - 10, 2003, Arlington, VA. Registration

FDA Clinical Trials and GCP Conference, June 25 and 26, 2003 at the Pittsburgh Marriott Center City Hotel, 112 Washington Place, Pittsburgh, PA Conference Description and Registration Form.  Agenda

ICH Public Meeting; June 24, 2003 : Preparation for ICH Meetings in Brussels, Belgium, July 15-18, 2003 and ICH 6 Conference in Osaka, Japan, November 12-15, 2003.  Agenda

Evaluating Drug Names for Similarities: Methods and Approaches, Public Meeting (name changed from "Minimizing Medication Errors - Evaluating the Drug Naming Process"). June 26, 2003, The Renaissance Washington DC Hotel.  Meeting Information Meeting Agenda

Drug Quality System: cGMP’s for a New Era - 2003; An FDA/Industry Workshop.  June 16, 2003, East Rutherford, New Jersey.  Program and Registration Form

Creating New Knowledge, FDA & Industry in Dialogue. A conference between FDA and industry, sponsored by Temple University School of Pharmacy on April 15, 2003, at the Philadelphia Marriott, in Philadelphia, PA.  Agenda and Registration Form

Joint DIA/FDA/NASPE Workshop on QT Prolongation, January 13 - 14, 2003, The University of Maryland at Shady Grove, 9630 Gudelsky Drive, Rockville, MD. FDA’s Center for Drug Evaluation and Research (CDER) and Health Canada’s Therapeutic Products Directorate (TPD) have collaborated on a preliminary concept paper providing recommendations to drug developers concerning the design, conduct, and interpretation of clinical studies intended to assess the effects of new agents on the QT interval. To facilitate stakeholders’ and cardiac specialists’ input into the document, a workshop in co-sponsorship with the Drug Information Association (DIA) and in collaboration with the North American Society of Pacing and Electrophysiology (NASPE) will be held on January 13 - 14, 2003.
Registration Information
Preliminary Concept Paper

Satellite Broadcast:  ICH Q7A Good Manufacturing Practice Guidance for APIs and Its Use During Inspections.  August 21, 2002 
(Presentation) 

Risk Management of Prescription Drugs Public Meeting on May 22, 2002

Pharmacogenetics/Pharmacogenomics In Drug Development and Regulatory Decision-Making, May 16-17, 2002 (3/12/2002) 

CDER Live!" Satellite Video Conference PDUFA II and Electronic Data Submissions March 16, 1999 (Posted 3/9/1999)

CDER Live! Managing Medicines' Risks-Do We Have the Answers?",  March 1, 2002, satellite broadcast 1-4PM ET.  See DIA web site for registration information.

CDER Live!  PDUFA III: Building on Success. A joint production of the Center for Drug Evaluation and Research and the Drug Information Association, November 5, 2002.  [PDF] (10/3/2002)

Clinical Pharmacology during Pregnancy: Addressing Clinical Needs through Science, December 4-5, 2000 (updated 11/8/2000)

Clinical Trials 2000: FDA/Industry Exchange Workshop on Clinical Research Involving Human Drugs, Biologics and Medical Devices, October 5-6, 2000  (8/4/2000)

Consumer Roundtable December 13, 2000
Dr. Janet Woodcock's Presentation.  HTML or  PowerPoint. Also see: FDA Roundtable Page

Current Status of Useful Written Prescription Drug Information for Patients: Public Workshop. DoubleTree Hotel, Rockville, MD. February 29 - March 1, 2000  (updated 2/25/2000)

FDA and the Internet: Advertising and Promotion of Medical Products (Public Meeting) Minutes and Proceedings
The objective of this meeting is to discuss issues related to the advertising and promotion of prescription drugs (human and animal), biologics, and medical devices over the Internet. Consumers, patient groups, health care professionals, manufacturers of FDA-regulated medical products, information vendors, and other interested persons are invited to attend.

FDA/Industry Exchange Workshops on Scale-Up and Post Approval Changes (SUPAC), Supplements, and Other Post Approval Changes, December 8, 2000 (7/26/2000)

FDA/Industry Meeting on Preclinical Assessment of Reproductive Toxicity Data, June 24, 1999 (Posted 6/2/1999)

FDA/Industry Container Closure Guidance Training Session, October 26, 1999, Rockville, Maryland. (Posted 9/30/1999)

FDA's New Approach to Plant Inspections: Systems Inspections 2002 - An FDA/Industry Workshop.  Three sessions offered:  6/17/2002, 7/15/2002, and 8/5/2002. Federal Register notice.   [Agenda and Registration ]  (3/29/2002)

Fresh Air 2000 - Medical Gas Requirements, Satellite Broadcast, March 15, 2000 (2/4/2000)

Informal Discussion of PET Drugs: Development of Current Good Manufacturing Practices and Approval Procedures, September 28, 1999

Informal Discussion of Positron Emission Tomography (PET) Drugs: Approval Procedures, March 22, 2000 (3/10/2000)

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Impurity Guidelines in Theory and in Practice, April 27-29, 1999
or [Rich Text Format], Wyndham Palace Hotel Lake Buena Vista, Florida (Posted 2/26/1999)

Laboratory Good Manufacturing Practices (GMPs) 2000: FDA/Industry Workshop, Four Dates and Locations: (4/28/2000)
August 7 (California), August 28 (New Jersey)  

Manufacturing, Packaging, Laboratories, Services Contracting & Outsourcing August 27, 2001 (7/16/2001)

MedDRA (Posted 3/9/2000)
An extensive training schedule is being offered for MedDRA, the Medical Dictionary for Regulatory Activities, a global standard medical terminology for use in drug development activities and the health effects of devices. Training is designed for medical information personnel, clinical research associates, and others involved in the drug development and reporting process. Course descriptions and schedules for training in the United States, Canada, Europe and Japan are available from the MedDRA Site.

Open Public Meeting on FDA'S Draft "Guidance for Industry: Developing Medical Imaging Drugs and Biologics + [Agenda] (3/22/1999)

“Physiologically-Based Pharmacokinetics (PBPK) in Drug Development and Regulatory Science”, May 29-30, 2002, Center for Drug Development Science (CDDS) Georgetown University Medical Center, Georgetown University Conference Center, Washington, DC. [Agenda and Registration] (2/12/2002) 

Pediatric Oncology Drug Development July 18, 2002. The American Academy of Pediatrics, the Children's Oncology Group, the Alliance for Childhood Cancer, the National Cancer Institute and the FDA are co-sponsoring a workshop on pediatric oncology drug development on July 18th from 8:30 AM to 4 PM in the Advisors and Consultants Conference Room at 5630 Fishers Lane, Rockville, MD

Regional Workshops on Stability Testing and Control: June-August, 1999 (Updated 7/22/1999)

Roundtable on Research and Development of Drugs, Biologics, and Medical Devices: Rational Therapeutics for Infants and Children, May 24-25, 1999  (Posted 4/20/1999)

Safe Medical Treatments: Everyone Has a Role: Ensuring the Safety of Drugs, Biologics, and Medical Devices in Health Care, March 27, 2000 (3/14/2000)

Safety Issues Associated with Dietary Supplement Use During Pregnancy, March 30, 2000 (updated 4/20/2000)

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FDA/Center for Drug Evaluation and Research
Last Updated: October 5, 2004
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