18th Annual Pharmacovigilance 2019 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pharmacovigilance requirements, and to improve their organization’s compliance with pharmacovigilance requirements. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharmacovigilance development.
SPONSORS:
Gold Sponsor: APCER LIFE SCIENCES
Bronze Sponsor: BROOKWOOD, Pharma Solutions Internation GmbH
KEY SPEAKERS:
JACKIE ROBERTS, Executive Director Regulatory, Pharmacovigilance and Medical / QPPV, Accord Healthcare
JABEEN AHMAD, Regional PV Director, EEMEA, Abbvie
SUSAN WELSH, Chief Safety Officer, CSL Behring (USA)
RICARDA TIEMEYER, Head of Drug Safety & PoC Medical Information, Roche
PAOLO VOLTOLINA, Associate Director Regulatory Affairs, CSL Behring
MIROSLAVA NOVAKOVA, Medical Advisor, Sanofi Pasteur (Slovak Republic)
YUUNG YUUNG YAP, Senior International Regulatory Counsel, EU and International Regulatory Law, Pfizer
DAVID JEFFERYS, Sr. VP Regulatory, Eisai
TANJA PETERS, Global Head of PV Intelligence, Deputy EU QPPV, Boehringer Ingelheim
JOHN SOLOMON, Head of Pharmacovigilance - UK & Ireland, Sanofi
SUMIT MUNJAL, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda Pharmaceuticals
MICHAEL BEAN, Senior Director, Regulatory Compliance R&D, Johnson & Johnson
STEINAR MADSEN, Medical Director, Norweigen Medicines Agency
PAUL WANG, Director, Safety Science, Kite Pharma (USA)
DORIS STENVER, Chief Medical Officer, Member of the Pharmacovigilance Risk Assessment Committee (PRAC), Danish Medicines Agency
ALEJANDRA PADOVANI, Safety Scientist, Roche
SABINE POLTERMANN, Head Scientific Product Information, Novartis
HEINZ WEIDENTHALER, Director Pharmacovigilance, QPPV, Bavarian Nordic
MIRCEA CIUCA, Global Head Medical & Clinical Drug Safety, Vifor Pharma
FRANCK SCHWARTZ, QA Global Inspection, Intelligence Lead - Compliance and Regulatory Affairs, Novartis
ALINA TUDOR, Associate Director, Senior PV Physician/Deputy EUQPPV, Norgine
RAJ BHOGAL, Safety & International Director, Regulatory Inspections, R&D QA&C, Shire Pharmaceuticals
Plus many more
KEY THEMES:
Brexit Implications for the UK Pharmaceutical (pharmacovigilance) Industry
What would 'no deal' mean for medicine?
New Technologies in Pharmacovigilance (AI/ Machine Learning, IoT)
Quality, Safety and Signal Detection - Future of 2020
PV Audit & Inspections – Knowing what is to be done
Drug safety work in the pre-clinical/clinical transition and early clinical development phase
Pharmacovigilance in 2020 - future horizons and efficiencies
Updates towards of legislation, policies, systems, technology, communication strategies and best practice in PV
Possible effects of Brexit on Pharmacovigilance
Benefit/Risk ratio: the common denominator
Market analysis – What is our current stand? – Moving towards the new successful PV era
PV – Risk Management and Planning
Risk management in the lifecycle of a drug
Examining developments in GVP measures and status of the new Module VI
Improving in signal management and their implications
Latest updates and hot topics relating to the role of the QPPV
Challenges and Opportunities to optimize the overall PV ecosystem for maximum benefit
Quality, Safety and Signal Detection - Future of 2020
Medical devices – Increasing safety perspective
Case studies from various countries on the PV frameworks around the world
Good Clinical Practices and Good Pharmacovigilance practices
Proper communication - Sponsor – Site – CRO & Patients
Patient centric approach to help improve patient safety
Outsourcing activities - How to set it right?
How to involve patients better to develop drugs
The developing regulatory framework in advanced and developing markets – EU, USA & ROW
Accelerating new medicine introduction in developing world & overcoming challenges
Be part of a major networking opportunityWHO SHOULD ATTEND:
CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:
Pharmacovigilance, Pharmacoepidemiology, Pharmacogenomics, Drug/Product Safety, Drug Development, Information and Clinical Data Management, Clinical Pharmacology, Clinical Safety, Periodical safety update Reports, Risk Management, Research & Development, Quality Assurance, Patient Safety, Signal Detection, Safety Surveillance, Outcomes Research, Data Analysis, Epidemiology, Medical Affairs, Regulatory Affairs and Compliance, Information technology, Sales and Marketing
CONFERENCE SPONSORSHIP:
Email: kavitha@virtueinsight.co.in or TEL: +44 2036120886
Sponsor, Exhibition Stall (Booth) and a paid Speaker Slots are also available
We also have some sponsorship opportunities available for the event, which gives you an opportunity to sponsor/speak/exhibit, and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts.
CONFERENCE REGISTRATION:
Email: kavitha@virtueinsight.co.in or TEL: +44 2036120886
Introductory Offer (3 delegate places for the price of 2) - A huge saving discount and only Limited seats left.
Early Bird Discount (Ends 17th January 2019): Conference Delegate Pass (£950 + VAT per delegate)
Standard Registration (From 19th January 2019): Conference Delegate Pass (£1150 + VAT per delegate)Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
SPONSORS:
Gold Sponsor: APCER LIFE SCIENCES
Bronze Sponsor: BROOKWOOD, Pharma Solutions Internation GmbH
KEY SPEAKERS:
JACKIE ROBERTS, Executive Director Regulatory, Pharmacovigilance and Medical / QPPV, Accord Healthcare
JABEEN AHMAD, Regional PV Director, EEMEA, Abbvie
SUSAN WELSH, Chief Safety Officer, CSL Behring (USA)
RICARDA TIEMEYER, Head of Drug Safety & PoC Medical Information, Roche
PAOLO VOLTOLINA, Associate Director Regulatory Affairs, CSL Behring
MIROSLAVA NOVAKOVA, Medical Advisor, Sanofi Pasteur (Slovak Republic)
YUUNG YUUNG YAP, Senior International Regulatory Counsel, EU and International Regulatory Law, Pfizer
DAVID JEFFERYS, Sr. VP Regulatory, Eisai
TANJA PETERS, Global Head of PV Intelligence, Deputy EU QPPV, Boehringer Ingelheim
JOHN SOLOMON, Head of Pharmacovigilance - UK & Ireland, Sanofi
SUMIT MUNJAL, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda Pharmaceuticals
MICHAEL BEAN, Senior Director, Regulatory Compliance R&D, Johnson & Johnson
STEINAR MADSEN, Medical Director, Norweigen Medicines Agency
PAUL WANG, Director, Safety Science, Kite Pharma (USA)
DORIS STENVER, Chief Medical Officer, Member of the Pharmacovigilance Risk Assessment Committee (PRAC), Danish Medicines Agency
ALEJANDRA PADOVANI, Safety Scientist, Roche
SABINE POLTERMANN, Head Scientific Product Information, Novartis
HEINZ WEIDENTHALER, Director Pharmacovigilance, QPPV, Bavarian Nordic
MIRCEA CIUCA, Global Head Medical & Clinical Drug Safety, Vifor Pharma
FRANCK SCHWARTZ, QA Global Inspection, Intelligence Lead - Compliance and Regulatory Affairs, Novartis
ALINA TUDOR, Associate Director, Senior PV Physician/Deputy EUQPPV, Norgine
RAJ BHOGAL, Safety & International Director, Regulatory Inspections, R&D QA&C, Shire Pharmaceuticals
Plus many more
KEY THEMES:
Brexit Implications for the UK Pharmaceutical (pharmacovigilance) Industry
What would 'no deal' mean for medicine?
New Technologies in Pharmacovigilance (AI/ Machine Learning, IoT)
Quality, Safety and Signal Detection - Future of 2020
PV Audit & Inspections – Knowing what is to be done
Drug safety work in the pre-clinical/clinical transition and early clinical development phase
Pharmacovigilance in 2020 - future horizons and efficiencies
Updates towards of legislation, policies, systems, technology, communication strategies and best practice in PV
Possible effects of Brexit on Pharmacovigilance
Benefit/Risk ratio: the common denominator
Market analysis – What is our current stand? – Moving towards the new successful PV era
PV – Risk Management and Planning
Risk management in the lifecycle of a drug
Examining developments in GVP measures and status of the new Module VI
Improving in signal management and their implications
Latest updates and hot topics relating to the role of the QPPV
Challenges and Opportunities to optimize the overall PV ecosystem for maximum benefit
Quality, Safety and Signal Detection - Future of 2020
Medical devices – Increasing safety perspective
Case studies from various countries on the PV frameworks around the world
Good Clinical Practices and Good Pharmacovigilance practices
Proper communication - Sponsor – Site – CRO & Patients
Patient centric approach to help improve patient safety
Outsourcing activities - How to set it right?
How to involve patients better to develop drugs
The developing regulatory framework in advanced and developing markets – EU, USA & ROW
Accelerating new medicine introduction in developing world & overcoming challenges
Be part of a major networking opportunityWHO SHOULD ATTEND:
CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:
Pharmacovigilance, Pharmacoepidemiology, Pharmacogenomics, Drug/Product Safety, Drug Development, Information and Clinical Data Management, Clinical Pharmacology, Clinical Safety, Periodical safety update Reports, Risk Management, Research & Development, Quality Assurance, Patient Safety, Signal Detection, Safety Surveillance, Outcomes Research, Data Analysis, Epidemiology, Medical Affairs, Regulatory Affairs and Compliance, Information technology, Sales and Marketing
CONFERENCE SPONSORSHIP:
Email: kavitha@virtueinsight.co.in or TEL: +44 2036120886
Sponsor, Exhibition Stall (Booth) and a paid Speaker Slots are also available
We also have some sponsorship opportunities available for the event, which gives you an opportunity to sponsor/speak/exhibit, and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts.
CONFERENCE REGISTRATION:
Email: kavitha@virtueinsight.co.in or TEL: +44 2036120886
Introductory Offer (3 delegate places for the price of 2) - A huge saving discount and only Limited seats left.
Early Bird Discount (Ends 17th January 2019): Conference Delegate Pass (£950 + VAT per delegate)
Standard Registration (From 19th January 2019): Conference Delegate Pass (£1150 + VAT per delegate)Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
