Featured Speakers

Dr Dimitrios M Antoniadis Director of Pharmacovigilance  Pharmathen S.A	Dr Bert Van Leeuwen deputy Qualified Person for Pharmacovigilance (QPPV) Astellas Pharma Europe	György Zörényi MD,MFPM Global Patient Safety Physician AstraZeneca

Join your peer s and colleagues at our Pharmacovigilance Conference event.

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 Pharmacovigilance Conference will encompass six scientific areas:

• 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

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 
 Implementing the New EU Good Pharmacoviliance Practice Modules

- The new EU GVP Modules
- Patient Safety & Public Health  
- Impact of Modules of Pharmacovigilance Departments  

Dr Pipasha Biswas
Director & QPPV 
Symogen Ltd

11:00 
Morning refreshments

11:20
Pharmacovigilance: Contribution Towards Corporate Development 

- Pharmacovigilance metrics/ KPI’s 
- Pharmacovigilance Contribution towards patient safety 
- Pharmacoviliance as a business model

Dr Dimitrios Antoniadis
Director of Drug Safety & Pharmacovigilance
Pharmathen S.A

12:00 
Data Integration for Safety

- Need for & types of data integration 
- Trials versus epidemiological studies 
- ENCePP discussions at the EMA 

Dr Nawab Qizilbash
Head, 
OXON Epidemiology 

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 Anil Dhiri Causer
Consultant Business Analyst 
Oracle 

15:00
Afternoon refreshments 

15:20
Mobile Apps in Pharma Development

- Current Status of Healthcare/ Pharma /Apps 
- Potential Apps in Pharmaceutical R & D
- Developing Implementing and benefits of Apps 

Steve Hutson
Co-Founder 
Virtual PV Ltd 

16:00 
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 Kevin Woodward
Senior Consultant
TSGE

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 

Dr Gyogy Zorenyl
Senior Global Safety Physician 
Astrazeneca 

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 
Sanofi-Aventis (tbc)

10:20 
Quality Assurance within PV 

- The requirements of PV legislation 
- QA system set up 
- Metrics and KPIs 

Humaira Qureshi 
VP, Pharmacovigilance Outsourcing
Kinapse 

11:00
Morning refreshments 

11:20
Presentation to be announced  

Speaker to confirm
TBC 
TBC 

12:00 
Drug Safety on a Budget 

- Pharmacovigilance 
- Risk Management 
- REMs  

Dr Dennis Vargo
Head of Pharmacovigilance
AVEO Pharmaceuticals 

12:40 
Networking lunch 

13:40 
Presentation to be announced 

- To be confirmed 
- To be confirmed 
- To be confirmed  

Dr Ute Hoeffner
SEU QPPV
Novartis 

14:20
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 

Barton Corbet 
President
BLCMD Associates LLC  

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 

Barton Corbet 
President 
BLCMD Associates LLC 

Humaira Qureshi 
VP, Pharmacovigilance Outsourcing
Kinapse 

16:40 
Chair's closing remarks 

16:50 
End of conference 

Kinapse provides a broad range of services. Kinapse Consulting collaborates with clients in defining measurable improvements and successfully implementing operational changes. We have deep expertise and experience in life sciences operating strategy, organisation and process design, resourcing strategy, capability development and deployment and performance management. Kinapse Outsourcing provides cost-effective writing and analytical services for business critical information and documents for reporting and submissions.

Kinapse’s team of Pharmacovigilance experts have worked with some of the largest global pharmaceutical companies and Regulatory bodies in both consulting and outsourcing activities. Our outsourcing team is comprised of experienced pharmacovigilance experts who are dedicated to the Kinapse principles of quality, expertise and collaboration. Kinapse understand what the current PV legislation requires and the impact of the forthcoming changes in PV legislation to Regulatory Bodies and Marketing Authorisation Holders. 

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Book Now

Super Early Bird Price Avaliable Until: 5th October 2012 Super Early Bird Discount - (PV2012) Conference + 2 Workshops £1,299.00 GBP Conference + 1 Workshop £1,099.00 GBP 2 Day Conference £899.00 GBP Promotional Literature Insert £799.00 GBP Presentation CD Single User Licence £499.00 GBP Presentation CD Site License £1,399.00 GBP

Early Bird Price Avaliable Until: 26th October 2012 Early Bird Discount - (PV2012) Conference + 2 Workshops £1,499.00 GBP Conference + 1 Workshop £1,299.00 GBP 2 Day Conference £1,099.00 GBP Promotional Literature Insert £899.00 GBP Presentation CD Single User Licence £499.00 GBP Presentation CD Site License £1,399.00 GBP

Standard Price Standard Price - (PV2012) Conference + 2 Workshops £1,699.00 GBP Conference + 1 Workshop £1,499.00 GBP 2 Day Conference £1,299.00 GBP Promotional Literature Insert £1,399.00 GBP Presentation CD Single User Licence £499.00 GBP Presentation CD Site License £1,399.00 GBP