Symposium on Global Regulatory and Quality Standards in Clinical Trials

Venue: Bangalore

Location: Bangalore, India

Event Date/Time: Sep 17, 2005 End Date/Time: Sep 17, 2005
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Description

Clinical research takes a new dimension in India after the active involvement of regulatory authorities in recommending effective mechanisms.

Regulatory guidelines in India are now gaining acceptance & visibility after sustained efforts from the industry leaders, thus initiating a stronger emphasis on Quality mechanisms in the pharmaceutical industry.

This symposium will address the global quality standards, highlight the Indian scenario, illustrate case studies, and put forth recommendations for improvements. Pharma and CRO Industry leaders from India and abroad have been invited as speakers.

Introduction:

Clinical research takes a new dimension in India after the active involvement of regulatory authorities in recommending effective mechanisms. Regulatory guidelines in India are now gaining acceptance & visibility after sustained efforts from the industry leaders, thus initiating a stronger emphasis on Quality mechanisms in the pharmaceutical industry.

The latest Schedule Y has tremendous impact on design and management of clinical trials. This symposium will address the global quality standards, highlight the Indian scenario, illustrate case studies, and put forth recommendations for improvements. Pharma and CRO Industry leaders from India and abroad have been invited as speakers.

The symposium will be attended by mid to senior level executives from the clinical research, pharmaceutical and biotech organizations. In addition to the talks, two networking sessions have been organized.

The Speakers:

Keynote Speaker - Ms. Kumud Sampath, President, AstraZeneca
Moderator - Dr. P.K. Seth, CEO, Lucknow Biotech Park
A.Dr. G.P. Agrawal, Director, DEBEL
B.Mr. Ranjit Barshikar, Vice President - Global Quality, Ranbaxy
C.Dr. Saral Thangam, Head Quality Affairs, Lotus Labs
D.Dr. Chandrasekhar Potkar – Director (Clinical Research), Pfizer
E.Dr. Ashwini K. Mathur, Sr. GM, GSK India,
F.Dr. Krathish Bopanna, CTO, Acunova
G.Dr. Sadasivan Pillai, Head, Quality R&D Orchid Chemicals
H.Dr. Saha, - Head, NGLP Monitoring Authority
J. Dr. Rajni Kaul, Asst. Director General, ICMR.
K. Dr. Ramani A Ayier, – Sr. VP Nicholas Piramal
L.Dr. B. Priya, Head – Q&C, Vaatsalya

The Organizers:

Vaatsalya, started in Nov 2004, is the first Indian company to provide Independent Audit and Monitoring Services for clinical trails. Vaatsalya also provides consultation and training to implement quality systems for clinical trails & clinical data management. Run by a team of professionals having more than 10 years of experience in conducting different phases of clinical trails, data management & auditing, Vaatsalya is a focused on quality and continuous learning.

This event is being organized jointly with IBAB (Institute for bioinformatics and applied biotechnology, Bangalore)

Contact:
Dr. Ashwin Naik
President,
Vaatsalya Healthcare Solutions Pvt. Ltd.
http://www.vaatsalya.com

Venue