Vision and Mission

The Founders of the ACDRS envision a modernization of the development and regulation processes for new medical products.

This modernization will be accomplished through comprehensive instruction for integrating the cutting-edge concepts and best practices of medical product development and regulatory sciences.

The Goals of the ACDRS are to:

• Present a foundation of integrated knowledge in science-based medical product development and regulation
• Enable application of innovative methods, tools and strategies that best utilize recent scientific advances and technologies to medical product design, development and regulatory review
• Address real world challenges encountered during the development, manufacture, review and commercialization of FDA regulated medical products
• Provide an understanding of the entire medical product lifecycle–from molecule or device concept to marketplace
• Train the future leaders and integrators for medical product development
• Understand future directions in global pharmaceutical and health economics and business environments, and implications for product development and evaluation
• Provide an understanding of the consumer protection culture and changing approaches taken by regulatory bodies

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Program

The ACDRS consists of 24 teaching days divided into six sessions over a period of two years (eight hours per day, each lesson 45 minutes), including “team” involvement in mentored, case-oriented workshops. In addition, approximately eight hours of preparation per session is required in order to prepare for the case study workshops. Distance learning formats are in development.

Teaching Faculty

The ACDRS teaching faculty will consist of international experts in regulatory sciences, medical product discovery and development, product evaluation and business practices. Lecturers and mentors will be drawn from academia, regulatory agencies (such as the FDA, EMEA, MHRA and other regulatory agencies), pharmaceutical, device, diagnostic and biotechnology industry, coverage and reimbursement organizations, professional societies and the National Institutes of Health.

Who Should Attend this Course?

This Course is targeted for the biopharmaceutical industry and its service industries, academic and government scientists, and decision- and policy-makers who have a good grounding in the basics and will benefit from a more in-depth, comprehensive and systematic immersion into modern medical product development, regulation and market introduction.

This Course emphasizes integrated product development which is science-based, efficient, economical, high quality and rapid - leading to better and safer medical products for patients.

This Course targets the following professionals:

• Drug Discovery and Non-Clinical Development Team Leaders
• Drug Discovery and Translational Scientists from Academia and Industry
• Drug and Medical Device Product/Clinical Development Team Leaders and Members
• Clinical Pharmacology and Development Team Leaders, and Clinical Scientists
• Therapeutic Area and Technology Platform Managers
• Regulatory Scientists from Industry, Academia and Government
• Portfolio, Program and Project Managers and Team Leaders
• Knowledge Transfer, Partnering, Licensing and Legal Experts
• Heads of Research and/or Product Development and Business Executives
• Investors from Venture Funds and Financial Institutions

What Will You Gain from Attending this Course?

Participants of this Course will be able to understand how to incorporate the latest innovative biopharmaceutical development strategies, methodologies and tools to:

• Be prepared for future developments and changes of the global pharmaceutical, health economics and business environments, as it impacts product selection, product development, regulatory and business evaluations
• Design, evaluate and manage integrated product development programs and the resulting pharmaceutical R&D portfolio
• Devise timely Go/No Go decision-making criteria and procedures based upon critical analyses of non-clinical and clinical data sets leading to improved success rates for new drug candidates and devices
• Incorporate into milestone decisions, including early-on, the potential commercial value of development candidates/products and their return on investment
• Address real world challenges encountered during the development, manufacturing, review and commercialization of FDA regulated medical products
• Prepare and critique an integrated product development plan
• Optimize and critique clinical and non-clinical protocols
• Incorporate integrated product safety management programs
• Design a global NDA/MAA registration strategy for rapid market approvals
• Incorporate present and future regulatory policies, guidances, and opportunities into FDA meetings with sponsors and NDA reviews
• Effectively understand and network a given corporation’s structure and functions
• Understanding legal basis of regulatory authorities and current developments
• Prepare for the next career step

Tuition Fee

The early bird tuition fee for the ACDRS Cycle 2 in Washington, DC is $15,000 ($625 per day, $2500 per session with six sessions over two years) and will increase by ten percent after September 1, 2009. Companies may reserve participant slots with payment on or before September 1 to ensure participation in the second cycle of this Course in Washington, DC.

For those registering after September 1, 2009, the entire tuition fee is $16,500. Full payment is made at the time of registration or may be done in two installments, with the first payment at the time of registration (no later than July 15, 2009) and the second payment by July 15, 2010.

The fee for this nonprofit, academically based course is inclusive of course material, lunches, coffee breaks and final examination. It does not include other meals or accommodations.

In case of cancellation before August 1, 2009 the fee (less $900.00 for administrative expenses) will be returned. There will be no substitute registrants or refund on cancellations made after this date. Should a Course session be postponed due to events beyond the control of the University of California, San Francisco, tuition will be applied to a rescheduled session.

A discounted fee for a limited number of participants from academia and government is available, please contact jaime.kenyon@ucsf.edu.

Venue

The ACDRS 2009-2011 is to be held at the University of California (UC), Washington Center (1608 Rhode Island Ave, NW, Washington, DC 20036). The UC Washington Center is located in the heart of downtown DC, near two metro lines and a short walk from Dupont Circle and the White House. A parallel ACDRS 2008-2010 is held at the Mission Bay Conference Center at UCSF (1675 Owens Street, San Francisco, CA 94158). The Mission Bay Conference Center at UCSF is located on UCSF's new 43-acre life sciences campus for teaching and research, located just south of downtown San Francisco and convenient to the Bay Area.

Continuing Education Credit for 2008-2010 San Francisco Cycle

The University of California, San Francisco (UCSF) School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

This course is eligible for ACPE credit. Please see final announcement for specific details.

Board and Committees

The University of California, San Francisco, CA 94143, 415/476-9000
Copyright © 2009, The Regents of the University of California.