Day Two - Thursday 19th April 2012

last modified: 10 April '12

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DRUG SAFETY: BEST PRACTICE

7.40am

Registration

8am

Breakfast Seminar hosted by Sciformix

Start the day with this engaging discussion session and complimentary breakfast, hosted by Sciformix Corporation.

POST AUTHORISATION SAFETY

9.15am

The role of pharmacoepidemiology in drug safety

Yola Moride

Yola Moride has received degrees in Genetics (MSc) and Pharmacoepidemiology (PhD) from McGill University and has trained as a Post-doctoral Fellow at the Pharmacovigilance Centre at the University of Bordeaux (France). Professor Moride has over 18...

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• Real world examples showing the vital role pharmacoepidemiology plays in ensuring patient safety

› Yola Moride, Associate Professor, Université de Montréal

9.45am

Enabling proactive safety - “Partnership-driven approach”?

Srivatsan Nagaraja

Srivatsan has more than two decades of experience in the Information Technology industry and deep knowledge of the Life Sciences domain. He has been responsible for providing leadership for growing Cognizant’s Life Sciences practice that includes...

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Krishna Rajagopalan

Krishnan has over fifteen years of experience in Global Sourcing Advisory Services, management, IT and technology consulting, and pharmaceutical R & D. Krishnan has global responsibility for Cognizant’s Life Sciences BPO strategy, P&L, and...

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- How to establish pharmacovigilance and surveillance models that are proactive
- How do you ensure that these organizations can serve regulatory authorities not only in mature markets but globally

10.15am

Use of patient and drug registries in observational epidemiology safety studies

Dr. Jerzy Tyczynski

Dr. Jerzy E. Tyczynski has been a Director, Risk Management and Pharmacoepidemiology at Astellas Pharma Global Development, Inc. since November 2011. Dr. Tyczynski has 25 years of experience in designing and conducting epidemiology studies. He has...

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• Epidemiology and pharmacoepidemiology in drug development process.
• Sources of data for observational safety studies.
• Registries as a source of data for drug safety assessment.
• Examples of safety studies using registry data.

› Dr. Jerzy Tyczynski, Director, Risk Management and Pharmacoepidemiology, Astellas

10.45am

PSURS- How can we ensure that we do this in a smarter way?

Rudi Scheerlinck

Rudi Scheerlinck is a certified GP (VUB, Brussels) who holds a Post-graduate Program in Pharmacology and Pharmaceutical Medicine (ULB, Brussels). During 14 years of pharmacovigilance experience, he has gained experience in a broad area of...

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• Increased demand for these reports
• How companies can cope?
• How to do these reports effectively?
• How might new ICH and EU guidance affect content of PSURs?
FDA and PSURs

› Rudi Scheerlinck, Executive Director,Integrated Medical Safety, Novartis Oncology

11.15am

Morning refreshments

11.45am

Panel session: The future of post authorisation safety- where are we heading?

Milbhor D' Silva

Milbhor D’Silva is a transplant and multiorgan procurement surgeon by background. His clinical work was complemented by live animal research using solid organ models of transplantation. His pharmaceutical medicine career spans 14 years. Over this...

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Jeanne Michaels

Jeanne Michaels is a Registered Nurse with a background of clinical work in various medical-surgical clinical arenas. She was an Associate Professor of Nursing at Purdue University followed by medical management positions in the health insurance and ...

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SAFETY IN SPECIAL POPULATIONS

12.15pm

New trends in drug safety assessment during pregnancy

Diego Wyszynski

Dr. Diego Wyszynski is Medical Director and Head of Maternal and Pediatric Safety (MAPS) at Amgen Inc. Trained as a pediatrician in his native Argentina, Diego obtained masters and PhD degrees in Epidemiology from Johns Hopkins University and...

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- How does Pregnancy differ from all other Drug Safety areas?

- How to establish your own Pregnancy Surveillance Program

- How to analyze and communicate pregnancy exposure and outcome data

› Diego Wyszynski, Medical Director and Head, Maternal and Pediatric Safety (MAPS), Amgen

12.45pm

Lunch

INFRASTRUCTURE REQUIREMENTS

1.45pm

Regulatory Ripple Effect for Quality and Training in Drug Safety Organizations

Nancy Grey

Dr. Grey is Director, Pharmacovigilance Education and Process Documentation in the Worldwide Safety Strategy organization at Pfizer, Inc. in New York City. Nancy started her career as a Chiropractic Physician with a private practice in...

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Virginia Klunder

Virginia (Ginny) Klunder is a seasoned healthcare professional with more than 14 years of pharmaceutical industry experience in global regulatory and drug safety quality and compliance management. She is an ASQ certified Manager of...

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DRUG SAFETY: BEST PRACTICE

2.15pm

Elements for Successful Pharmacovigilance Agreements

Angela K Pitwood

Angela Pitwood is the Vice President of Pharmacovigilance at IndiPharm. Angela is responsible for the ongoing development and management of IndiPharm’s pharmacovigilance (Pv) operations. With over 20 years of experience in the pharmaceutical...

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• Managing operational challenges
• Balancing pharmacovigilance agreements with other business processes

› Angela K Pitwood, Vice President, Pharmacovigilance, IndiPharm

2.45pm

Safe access to innovative therapies: when and why safety surveillance can fail

Hoda Eid

Hoda Eid holds a Ph.D. from the Université de Montréal in Canada and a Post-Doctoral fellowship from the Brigham and Women’s Hospital and Harvard Medical School in Boston. She returned to Canada in 1992 as an Assistant Professor at the University...

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- Evolving global pre-market safety surveillance landscape
- Challenges in the current regulatory environments
- Operational barriers: Importance of standardised techniques
- Impact on drug development and drug safety
- Regulator's perspective

› Hoda Eid, Manager, Adverse Drug reactions division, Health Canada

3.15pm

Investing in the future of pharmacovigilance in the developing world to ensure high returns

Vivek Ahuja

Dr. Ahuja is currently Director, Asia Pacific for Baxter Healthcare. He is based in India and is responsible for driving the strategic direction, implementation and maintenance of a high performing Pharmacovigilance function for Baxter in...

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› Vivek Ahuja, Director Pharmacovigilance, Baxter Healthcare Asia Pacific

3.45pm

Afternoon refreshments

4.15pm

How personalised medicine and the co development of therapeutics and diagnostics is influencing benefit risk management in decision making

Michael Forstner

Dr. Michael Forstner is “Integrated Safety Risk Manager” at F. Hoffmann-La Roche in Basel. In this role his main duties are to develop and implement processes for the coherent and consistent global management of drug safety risks together with his...

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- The co-development of therapeutics and diagnostics based on a variety of biomarkers is currently re-shaping the pharmaceutical industry.
- Many diagnostics are based on safety relevant biomarkers, thus enabling early identification of patients at higher risk from a particular treatment. This has a direct but different effect on the benefit-risk balance of a drug for different patients.
- Patients and healthcare providers need to understand the impact of personalized medicine, other important stakeholders will need to adapt procedures to accommodate to the changing landscape.
- The industry, regulatory authorities, and medical societies will have to work together to provide patients and physicians with a toolbox to enable fact based decision making on a particular treatment.