Day one PM - Wednesday 18th April 2012

last modified: 10 April '12

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3.45pm

Afternoon refreshments

4.10pm

Opening Remarks from the Chair

Shirish Dattatraya Sherlekar

Dr Shirish D Sherlekar is a trained doctor by profession. He have worked for five years at the P.D. Hinduja Hospital and Research centre as a resident surgeon and the Hospital of the Kaiga atomic power plant as a Medical director before shifting to...

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› Shirish Dattatraya Sherlekar, Global head life sciences practice, Tata Consultancy Services

4.15pm

Right Shoring - Partnering for Success

Suzanne Guidera

Suzanne Guidera has 15 years of experience in various Patient Safety roles, including operations, management, and project management. She received an undergraduate degree in Biology with a minor in Psychology, and Masters in Business. She has been ...

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• What is partnership?
• How to select a partner?
• How to achieve quality, compliance etc in Partnership and how to enhance it
• What is needed for a Successful partnership Role of both the partners

› Suzanne Guidera, Opportunities Manager, Patient Safety Global Interface Organisation, AstraZeneca

SAFETY IN EARLY DEVELOPMENT

4.45pm

Preclinical safety considerations in support of clinical safety

George McCormick

Dr. McCormick is the Vice President of Drug Safety & Disposition with Cephalon, Inc., West Chester, PA and has administrative responsibility for the overall operations of nonclinical toxicology, nonclinical and clinical pharmacokinetics, drug...

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- Preclinical safety requirements for drug registration

- Classification of toxicities encountered in safety testing

-Concordance of animal and human toxicities

-Transition from preclinical to clinical safety relative to the life cycle of a drug

› George McCormick, Vice President : Head NCS Small Molecules, Teva Pharmaceuticals

CLINICAL SAFETY

5.15pm

The key clinical safety challenges

Jonathan Deutsch

Jonathan Deutsch, M.D. is a graduate of the University of Rochester and The Sackler School of Medicine. Dr. Deutsch completed his internship at Overlook Hospital in Summit, NJ, USA in the Department of Internal Medicine, and he completed his...

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• Signal Detection

• Analyzing safety data efficiently and effectively

› Jonathan Deutsch, Therapeutic Area Safety Head, Oncology, Johnson and Johnson Pharmaceutical R and D

5.45pm

The role DSURS are playing in the safety of a drug

Sindee Sommer

Dr. Sommer is a board-certified general internist with over 18 years of experience in pharmacovigilance and clinical safety. After graduating Alpha Omega Alpha from Cornell University Medical College, she completed an internal medicine residency at ...

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• The role that DSURs play in global drug safety planning