4th Annual Risk Management and Pharmacovigilance Summit
SUMMIT IS OVER!
SEE THE PAST SPEAKERS & CASE STUDIES
FROM LAST ANNUAL
Corporate Vice President
Global Head International Pharmacovigilance
Vice President, QPPV Office
PAST CASE STUDIES INCLUDE
Magnus NORDVP Global Patient Safety CVMD
Delivering Strategic Clinical Drug Safety and PhV – Learnings from AstraZeneca
The last few years AstraZeneca-MedImmune has developed the clinical drug safety and pharmacovigilance organisation to shift focus from routine license-to-operate and pharmacovigilance activities, to strategic support for decision-making for drug projects and products. This has included advancing predictive and reactive scientific approaches in drug safety, launching a new operating model and organisational structure and reducing the procedural framework over 60%, key learnings and case studies from this journey will be presented.
- Refocus from Routine License-to-operate activities to Strategic support for decision-making
- Novel Predictive Statistical methods and Mechanistic PK-PD modeling for safety
- Using Large Data Networks for Clinical Drug Safety and PhV-Risk Management
- Reducing the Procedural framework in a major global pharmaceutical company
- Off-shoring vs Outsourcing of routine safety tasks
Karsten LOLLIKECorporate Vice President
Learnings from PV Inspections (Europe and Arabic League)
Feedback from PV inspections are part of shaping the PV systems. The presenter will discuss findings from EMA PV Inspection, especially focus on IT-systems. The presenter will also highlight major findings from global PV inspections especially in Arabic countries where new PV legislation is enforced.
- PV Inspections
- Arabic League
- Literature Monitoring
- OC of in-coming cases
Jan CLEERBOUTDirector, Medical Safety Officer
Signal detection and management: a pharmaceutical industry perspective
and future approaches
- Different tools to support signal detection and safety monitoring
- Reaction monitoring reports, emerging safety issues
- Implementation of the pharmacovigilance legislation
- Scope and objectives of GVP module
- Involvement in signal detection and management
- New approaches to signal management
Mélanie ESSEVAZ-ROULETLead of Country Quality Oversight
Lydie MARCELONDeputy Director PV and RM
New Vaccine launch – how to improve PV awareness and reporting in low middle income countries
The introduction of a new Dengue vaccine was targeting the first launched in low and middle income countries through mass vaccination campaigns. The LMIC countries have heterogeneous PV systems and some require capacity building.
In this context, the ultimate objective is to avoid to jeopardize the mass vaccination campaign after launch due to a lack of information regarding the safety of the vaccine / minimize the risk of media crisis and false signal. Stimulation of AEs reporting by patients/HCP is critical to further characterize the safety profile of our new vaccine in real life setting.
- Implement an easy-to-use web and interactive solution to collect the PV data from HCP through PC, tablets and smartphones.
- b-Set-up a prospective multi-national non-interventional post-authorization safety study consisted of a Cohort Event Monitoring using standardized data collection instruments through patient cards to be distributed to 30 000 vaccines & electronic Case Report Form to be filled in by HCPs.
WE ARE LOOKING FORWARD TO WELCOMING YOU ON BOARD IN 2018!
2017 CONFERENCE TOPICS
- Pharmacovigilance Trends – Global Harmonization
- PV Regulatory Aspects
- Social Media and Networks
- Outsourcing – The Benefits and Challenges
- Signal Detection and Signal Management
- Strategic Clinical Drug Safety
- Good Pharmacovigilance Practices
- PV Database Management
- Pharmacovigilance Significance and Scope
- Clinical Data Management
Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors, Heads of departments from Pharma industry / industries involved in:
- Drug/Product Safety
- Drug Development
- Information and Clinical Data Management
- Clinical Pharmacology
- Clinical Safety
- Risk Management
- Research & Development
- Quality Assurance
- Patient Safety
- Signal Detection
- Safety Surveillance
- Outcome Research
- Data Analysis
- Medical Affairs
- Regulatory Affairs and Compliance
- Information technology
- Sales and Marketing
The future trends
- New technologies and innovative methods in pharmacovigilance are emerging, but do you know how to utilize them?
- Dive deeper into safety and risk management issues and solutions in the EU through real-world experiences
- Enlightened evolution of regulatory science that speeds needed products to prescribers and patients
- Future strategies for growth in Pharma
- Engagement of patients in the future product development and regulatory processes
- Utilize new approaches to present benefit-risk data and communication of risk-benefit messages to health care providers, patients and consumers
PV Inspection readiness
- Would your organization be ready for an inspection of your pharmacovigilance system?
- What are the current FDA expectations?
- Discuss common missteps during the course or preparation
- FDA Pharmacovigilance inspection and its processes
- Explain the purpose behind pharmacovigilance inspections and their benefit
- Common inspection observations
- Plan and conduct a response to inspection observations