Regulatory Pathways of Vaccines for Global Diseases

CONFERENCE OVERVIEW

This global vaccine development symposium will address the expanding need for discussion on regulatory guidelines for the development of vaccines for infectious diseases. Professionals from industry and worldwide regulatory agencies will present the current challenges and solutions around this critical field of global healthcare. Ethical and cultural perspectives will also be presented by members of organizations such as World Health Organization (WHO), The Bill and Melinda Gates Foundation, International Vaccine Initiative (IVI), Developing Countries Vaccine Regulatory Network (DCVRN), and BIO Ventures for Global Health (BVGH). In addition, specific focus will be given to the WHO prequalification process and the FDAAA voucher program as they relate to global vaccine

development for world health.

OBJECTIVES

·         Compare the role of the United States (FDA) and European (EMEA) regulatory authorities in facilitating the regulation of vaccines against global infectious diseases

·         Understand the impact of the WHO’s prequalification/procurement process on providing access to vaccines for global health

·         Review the voucher process established under FDAAA to create greater incentives for developing vaccines for global infectious diseases, and the economic and vaccine development implications of this process

·         Discuss the ethical challenges in assessing vaccines for global infectious diseases

·         Elucidate perspectives from industry, NGOs and developing countries on the regulatory challenges to global vaccine development

At the conclusion of this meeting, participants should be able to:

·         Compare the role of the United States (FDA) and European (EMEA) regulatory authorities in facilitating the regulation of vaccines against global infectious diseases;

·         Describe the impact of the WHO’s prequalification / procurement process on providing access to vaccines for global health;

·         Review the voucher process established under FDAAA to create greater incentives for developing vaccines for global infectious diseases, and the economic and vaccine development implications

·         of this process;

·         Discuss the ethical challenges in assessing vaccines for global infectious diseases;

·         Recognize perspectives from industry, NGOs and developing countries on the regulatory challenges for global vaccine development.

This program will benefit individuals involved in

·         Clinical Research and Development

·         Clinical Safety/Pharmacoepidemiology/Pharmacovigilance

·         Pharmacology

·         Quality of Life/Health Economics/Outcomes Research

·         Quality Control/Quality Assurance

·         Regulatory Affairs/Policy/Drug or Device Approval/GRP

·         Research and Development/Strategic Issues

·         Pharmaceutical Senior Executive Level/Business Leaders

Attendees may visit the tabletop exhibits during the event and during receptions (if applicable).

Event information: Contact Jo Ann Boileau at the DIA office by telephone +1-215-442-6175, fax +1-215-293-5940 or email JoAnn.Boileau@diahome.org.

Tabletop exhibit information: Contact Shannon Lewis, Exhibits Associate, at the DIA office by telephone +1-215-442-6149, fax +1-215-442-6199 or email Shannon. Lewis@diahome.org. For tabletop exhibit space, please check the box below.

09023
Global Vaccine Development for World Health Symposium
FDA, EMEA, Emerging Regions, NGO, and Industry Perspectives

Fee:
Tabletop…………………$1,500.00

Tabletop Rental Fee includes:
     • One (1) 6' skirted table;
     • One (1) chair;
     • Standard electricity
Each Tabletop rental requires at least one registered attendee to staff the table. All tabletop staff is required to register as an attendee for the conference.

Exhibits Show Dates:
November 3-4, 2009
Marriott Bethesda North Hotel
5701 Marinelli Road
North Bethesda, MD 20852-2785

DIA Exhibits Contact Information:
Shannon Lewis
Exhibits Associate
+1-215-442-6149
Shannon.Lewis@diahome.org

Useful Links:
~ Application for Tabletop Display

	Accelovance
	MD ,
	Thymed GmbH

The most convenient airport is Reagan National Airport and attendees should make airline reservations as early as possible to ensure availability. The Marriott Bethesda North Hotel and Conference Center is holding a block of rooms at the reduced rate below until October 12, 2009, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.

Single $179          Double $179

Please contact the Marriott Bethesda North Hotel and Conference Center by telephone at +1-301-822-9200 and mention the DIA event. The hotel is located at 5701 Marinelli Road, Bethesda, MD 20852, USA.

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.