Research and Markets: 2nd Pharmacovigilance Global Summit Pharmacovigilance and Risk Management Strategies: New Advances
Business Wire, Inc. |
Join your peers and colleagues at our
The objective of this conference is to provide communication, education and networking opportunities for scientists engaged in Pharmacovigilance whether in academia, biotech or industry.
Attendees will hear world-class speakers discussing the challenges and opportunities facing the Pharmacovililance field.
Our
- New harmonization initiatives in pharmacovigilance
- New strategies in benefit risk optimization, risk communication, labelling & packaging
- Addressing drug counterfeiting issues & evaluating possible measures to combat & protect consumers
- EU and US reforms in pharmacovigilance legislation
- The economics of pharmacovigilance and pharmacoepidemiology
- Preparing for product specific inspections & compliance monitoring by authorities
Agenda:
DAY I
09:00
Registration and refreshments
09:30
Opening address from the chair
Dr Gyogy Zorenyl
Senior Global Safety Physician
Astrazeneca
09:40
Current challenges facing the pharmacovigilance industry
- Achieving QbD objectives
- QbD and continuous improvement in manufacturing
- Design space and control strategy
- The use of MVDA models to ensure quality compliance in routine production
Eileen Evelaar
Ass Director of Pharmacovigilance
Astellas Pharma
10:20
Environmental aspects of Human and Veterinary pharmaceuticals
- Adverse environmental effects part of veterinary pharmacovigilance
- Human and veterinary drugs ubiquitous in environment
- Human health effects unknown
Dr
Senior Consultant
TSGE
11:00
Morning refreshments
11:20
The impact of EMAs announcement to make submission of EVMPD data mandatory
- Data requirements and timelines
- Impact assessment
- Technology and process options for market authorization options
Dr
Managing Director,
Marr Consultancy
12:00
Benefit Risk-Management Systems
- Use of evidence based toolbox for risk minimisation
- PASS and PAES
- Examples of benefit risk management plans
Dr
CEO,
Pharminvent Services
12:40
Networking lunch
13.40
Effective risk management: strategies to leverage patient safety
- Safety specification
- New aspects of the pharmacovigilance plan
- Effective risk minimization and risk communication
Dr Gyogy Zorenyl
Senior Global Safety Physician
Astrazeneca
14:20
Integrating Clinical Safety & Spontaneous Reporting
- Challenges for System integration
- Optimism business processes
- Regulatory Challenges
Dr
Consultant Business Analyst
Oracle
15:00
Afternoon refreshments
15:20
Pharmacovigilance in the age of real world data
- The need for real World Data
- Demonstrating how FDA AERS data and the GPRD can be analyzed from the desk top to support drug safety
- The future potential for electronic patient records in pharmacovigilance
Managing Director
16:00
Available Speaker position
16:40
Closing remarks from the chair
16:50
Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.
DAY 2
09:00
Registration and refreshments
09:30
Opening address from the chair
09:40
Case study: customer experience and risk orientation in case management
- Defining the strategic direction of the pharma company
- Risks and benefits of drug safety measures
- Impact of pharmacovigilance on marketplace and pharma company
- Manufacture of drug safety commodity products
- Manufacture of products using proprietary technologies
Katba Achur
Case Medical Evaluator Leader
10:20
Quality Assurance within PV
- The requirements of PV legislation
- QA system set up
- Metrics and KPIs
VP, Pharmacovigilance Outsourcing
Kinapse
11:00
Morning refreshments
11:20
Risk Management: Principle and Practice
Vishnu Shyamal
Pharmacoviglance & Medical Information Manager
GSK
12:00
Drug Safety on a Budget
- Drug Safety and Risk Management
- Examine the costs of running PV and RM
- Examine the monetary aspects of out-sourcing
President
12:40
Networking lunch
13:40
Quality of Data, new business rules to create a more solid base for data mining and statistics
- New techniques in data mining and statistics
- Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs
- Governance and the management process
Dr
SEU QPPV
Novartis
14:20
Available speaker position
15:00
Afternoon refreshments
15:20
The future of pharmacovigilance within industry
Our expert panel will discuss and debate on the future and progression of pharmacovigilance opportunities and operational challenges to working
environments
Panel members will be drawn from the speakers who take part on day one or day two.
Dr Gyogy Zorenyl
Senior Global Safety Physician
Astrazeneca
President
VP, Pharmacovigilance Outsourcing
Kinapse
16:40
Chair's closing remarks
16:50
End of conference
Speakers
Key Speakers
- Dr
- Dr
- Dr
- Dr
- Ms
- Dr Katba Achur, Case Medical Evaluator Leader,
- Dr
- Dr
For more information visit http://www.researchandmarkets.com/research/dnmdfc/2nd_pharmacovigila
[email protected]
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceuticals
Source:
Copyright: | Copyright Business Wire 2012 |
Wordcount: | 841 |
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