DIA conference MUMBAI April28-29,08

DIA 1st Indian Annual Regulatory Conference Building Bridges Between the Regulators and the Pharmaceutical Industry: Indian Regulatory Landscape in the Next Decade

Date(s) And Time(s):
Apr 27 2008 9:00AM - Apr 29 2008 6:15PM

Location:
InterContinental The Grand Mumbai
-
Sahar Airport Road
Mumbai 400059
MH
India

Interest Area(s):
Academic Health Centers, Biotechnology, Clinical Data Management, Clinical Safety/Pharmacovigilance, Clinical Research and Development, Project Management, RA/Policy/Drug or Device Approval/GRP, R&D/Strategic Issues, Outsourcing/Virtual Development, Marketing/Advertising

Overview:

DIA 1st Indian Annual Regulatory Conference continues the DIA tradition of premier multidisciplinary, neutral, and international events.

This conference launches the establishment of a DIA office in Mumbai, and of the DIA provisional Advisory Council of India.

India has a strong need for an international forum that brings together industry, academia, and regulators to educate its drug development professionals on regulations, clinical practices, and safety standards that will impact the approval of drugs developed in India for a global market. Join regulators, industry epresentatives, and academia to share experiences and key objectives that will help to bridge the gap between regulators and industry over the next decade.

TRACK TOPICS

· Challenges and Opportunities in Quality

· Clinical Trials, Safety, and Postmarketing

TWO TUTORIALS – SUNDAY, APRIL 27, 2008

• Quality Overall Summary and Quality Modules • Good Clinical Practices

CONFERENCE OBJECTIVES

· Discuss the Evolving Indian and Global Regulatory Environment

· Recognize the Requirements of Indian Regulations

· Discuss Future Drug Development Science

· Identify Current Challenges around Quality, Safety and Efficacy

· Evaluate International Trends and Global Harmonization Opportunities

Registrations will be accepted by fax only.

Target Audience:

WHO SHOULD ATTEND

This program will benefit individuals involved in:

· Academia

· Clinical research and development

· Clinical safety and pharmacovigilance

· Clinical supply operations

· Clinical trial and project management

· Chemical Manufacturing Control (CMC)

· Compliance

· Data management

· Good clinical practices (GCP)

· Government and public policy

· Medical affairs

· Outsourcing management/contract research organizations (CRO)

· Quality assurance/Quality control

· Regulatory affairs and public policy

· Research and development

· Risk management

· Strategic planning and alliance