[india-drug] Workshop: Compliance in Clinical Drug Development

["Transworld" <prabhashankar@transworldtraining.org>]

International Workshop on
Compliance in New and Generic Clinical Drug Development
28th & 29th July 2006, Hyderabad

Organizers:  TransWorld Institute of Professional Development & Training
Indian Pharmaceutical Association - Industrial Pharmacy Division
*********** 

Dear Sir / Madam,

                  After seeing an overwhelming response from the Indian
Clinical Research Organizations and Pharma industry to our last year's
International workshop on Fundamentals of Clinical Trials, we have the proud
privilege in announcing our second International Workshop on the topic
Compliance in New and Generic Clinical Drug Development.

                  This forthcoming workshop will be organized jointly by
Transworld Institute of Professional Development & Training and Indian
Pharmaceutical Association - Industrial Pharmacy Division on 28th and 29th
July, 2006 at Hyderabad.

                  The main objective of this workshop would be to provide an
over view of different issues related to Clinical Trials compliance during
the clinical development of new and generic drugs. The hot topics to be
discussed in this

New Drug Development
1. Preclinical and clinical Studies in New Drug Development - Overview
2. Regulation of New Drug Development in US/EU/Japan
3. Overview of Generic Drug Approval Process.
4. Protecting Human Subjects in Clinical Research - GCP to avoid mistakes
5. Clinical Trials Management/ Site-Sponsor Interactions

Generic Drug Development
1. Role of IVIVC (In-Vitro In-vivo Correlation) and BCS
(Biopharmaceutics Classification) in Generic Drug Development
2. Standard Operating Procedures: Ensuring Good Clinical Practice (GCP) through SOPs
3. Standard Operating Protocols for Successful Clinical Trials and Complying with Regulatory Agency and Sponsor Inspections
4. Regulatory Process of Approving Generic Drugs
5. Bioequivalence Concept, Design and Analysis of bioequivalence Study

                  We are bringing internationally recognized and experienced
speakers to offer high quality of presentations on the above topics which
are of great interest to the Indian CROs.

1. Dr. Bhaskara R. Jasti, Co-Chair, University of the Pacific, Stockton, CA, USA
2. Dr. Raj Pradhan, Co-Chair, Abbott Laboratories, USA
3. Ms. Carolyln E. Rugloski, i3 statprobe, USA
4. Dr. Charles Pierce, President, Global Clinical Partners, Inc., USA
5. Dr. Balakrishna Hosmane, Northern Illinois University, USA
6. Dr. Yihong Qiu, Ph.D, Abbott Laboratories, IL, USA
7. Dr. Sandeep Dutta, Ph.D, Abbott Laboratories, IL, USA

                  This time we are going to organize live video conferencing
with our expert speakers on the topic Role of IVIVC (In-Vitro In-Vivo
Correlation) and BCS (Biopharmaceutics Classification) in Generic Drug
Development.

                  Also we are extending an exclusive one to one interactive
meeting for CRO companies and pharma industry professionals with our expert
speakers on the sidelines of the two-day workshop on first come first basis.
The charges for 45 min. interactive meeting is Rs.25,000/- (includes one
free delegate registration).

                  The registration charges for delegates is Rs.6,500/- and
Rs.7,500/- for spot registration. Please register at the earliest since we
accept only 200 delegates on first come first basis.

                  We request you to visit our website to know more about
this workshop and also can go through high lights of our previous workshop.

                  Programme Details (click here to download)

                  Registration form (click here to download)

Contact Person:
B. Prabha Shankar President,
Transworld Institute of Professional Training and
Development
Hony. Secretary, Indian Pharmaceutical Association -Industrial Pharmacy Division.
# 3-5-1094/13, 3rd Floor, Venkateshwara Colony, Narayanguda, Hyderabad - 500 029
Tel: 040 -55973522 Fax: 040-24751455
E.Mail: prabhashankar@transworldtraining.org
visit our website for more details at
http://www.tansworldtraining.org