IDMA – IPC – USP 9th Annual Scientific Meeting

Overview

The Indian Drug Manufacturers Association (IDMA) with co sponsorship from members of the USP India Stakeholder Forum sponsored the Indian Pharmacopoeia Commission – United States Pharmacopeia Convention 9th Annual Scientific Meeting. This meeting was supported a science-based dialogue to promote access to good quality medicines and dietary supplements/botanicals. Topics focused on the information related to regulatory requirements and compendial standards for drug products and their ingredients. This event was succeeded with the active participation of IPC, USP, US FDA, IP,NIPER, DCGI and Department of Science & Technology, Government of India along with Scientists from the Pharmaceutical and Biotech Industries, regulatory agencies, stakeholders and opinion leaders from across the globe.

The discussed topics at the event are as follows:-

• Discovery and Development of New Medicines in India

Plenary sessions:

• Advances in Medicines Regulation
• Approaches to Combat Counterfeit and Substandard Medicines
• Environmental Monitoring and Control Non-Sterile Manufacturing
• Compendial Initiatives and Updates

Parallel sessions:

• Measurement Science: General Approaches
• Biologics: Quality of Manufactured Medicines
• Herbals/Excipients/Food Ingredients
• GMP/Supply Chain Management
• Measurement Science: Analytical Methods
• Biologics: Monoclonal Antibodies, Recombinant Therapeutics
• GMP/Supply Chain Management Transportation

Visitor Profile:

USP-NF, FCC and USP Reference Standards users; scientists focusing on chemistry, drug substances, drug products, excipients, packaging, veterinary drugs and food ingredients; Government, Academia and Association Representatives; Regulatory Personnel, R & D and QC Personnel; laboratory supervisors / managers; compendial affairs representatives; statisticians; and technical consultants.

The meeting was of interest to manufacturers of medicines and their ingredients, exporters and importers of bulk pharmaceuticals; regulatory scientists, representatives of national drug control laboratories, professional and academic scientists, policy makers, and other interested parties.

Pharmacovigilance and Risk Management

Focused Area

Regulatory Affairs, Clinical Research, Public Policy/Law/Corp. Compliance, Research & Development, Project Management

Overview:

In the event, the experts addressed the "Current Complexities and Controversies in Pharmacovigilance and Risk Management". Product safety is a complex issue both for clinical trial safety and for post-marketing pharmacovigilance. This two-day workshop addressed the inherent limitations of marketing and testing for risk associated with medical products, the increased dimensions of risk management to product safety as a maturing discipline, and how to refine and enhance the value of risk management applications in the name of public health. In addition, the other topics, which discussed here, were Risk Management, National pharmocovigilance programme: Progress, Status and Challenges, KPO-Pharmacovigilance Model, Human Resource Development in Pharmacovigilance, Management of Pharmacovigilance the MNC Way.

Learning Objectives:

The learning objectives of this conference were to explain key aspects of current global safety reporting requirements for prescription and over-the-counter drugs and explain the application of epidemiological approaches during drug safety surveillance discuss the latest regulatory frameworks of pharmacovigilance in the US, Europe, Japan and Asia-Pacific. Besides the event described regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan

Applied Pharmaceutical Analysis 2010 - India

Applied Pharmaceutical Analysis 2010 - India was organised by Boston Society Inc to bring together the scintists from across the world to discuss & assess current state and of research and development in Pharmaceutical industry. The conference presented a great opportunity to establish a global community of practice specifically focused on the challenges facing scientists involved in the pharmaceutical industry today.

Aim

The goal of this inaugural APA conference was to bring together scientists from across India and the rest of the world to discuss and assess the current state of pharmaceutical research and development in the areas of Discovery and Regulated Bioanalysis, Biotransformation, Process Chemistry, and New Technologies as applied to the Indian Pharmaceutical industry.

India Lab Expo 2010

India Lab Expo 2010, the first exhibition of its kind held at Pragati Maidan, India. More than 200 major exhibitors and thousands of visitors from India and abroad were presented in the even. The India Lab Expo seminar was unique by combining extensive research with authoritative inputs from key industry figures; the seminar program provided an up-to-the-minutes overview of the major trends in laboratory technology. Knowledge transfer for the entire period of India Lab Expo and seminar are guaranteed.