Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:
Safety & Risk Management
Regulatory Affairs, Pharmacovigilance
PV Inspection and Audit Readiness
Patient Support Programmes
Market Research Programmes
Quality Assurance, Pharmacovigilance
PAST CASE STUDIES INCLUDE
CASE STUDY / DAY 1
Counterfeit of Pharmaceutical Products – What Are the Risks and How to Mitigate Them?
Counterfeiting of pharmaceutical products is a global health issue, that is a growing concern. According to PSI (Pharmaceutical Security Institute), in some countries more than 25% of the medicines sold are counterfeit and with increasing consumer purchasing of medicines online, counterfeiting can go up in all countries. The fight against counterfeiting is multidisciplinary and collaboration with health authorities and police is vital.
Counterfeiting – A global health issue
Counterfeiting – Are pharmaceutical companies responsible?
How to monitor for counterfeited products?
How to reduce the risk of counterfeiting?
Corporate Vice President and QPPV
G. Scott CHANDLER
Global Head, Personalised Health Care (PHC) Safety
CASE STUDY / DAY 1
Patient-Centric Approaches to Proactive Safety and Risk Management
Proactive safety and risk management requires a patient-centric approach in order to understand the potential drivers of toxicity and how to best mitigate them. Evolving capabilities in generic profiling, advanced analytics and increased understanding of disease biology provide new opportunities to characterise risk and intervene more specifically. The presentation will highlight some recent advances and novel approaches for evaluating toxicity and disease biology in order to demonstrate how proactive and patient-centric approaches can be applied to pharmacovigilance.
Proactive, patient-centric, and pharmacogenomics approaches to safety and risk management are key components of personalised healthcare
Pharmacogenomics are also a regulatory imperative and patient-centricity is expected by health authorities
Evolving capabilities in genetic profiling, advanced analytics and disease modelling provide new opportunities to predict and mitigate toxicity to better optimise the benefit/risk balance for individual patients
CASE STUDY / DAY 2
Inspection Readiness – How to Ensure It
This presentation will provide a brief overview of PV inspection topics and common questions, and also inspection readiness activities and examples to ensure being always ready for being inspected.
How to get ready for an inspection?
What are the questions commonly asked during an inspection?
How to identify issues before the inspection and avoid findings?
Begum BENLI PEKER
Associate Director, International Operations & PV Intelligence
Global Head Drug Safety and Risk Management
CASE STUDY / DAY 2
A Framework for Safety Evaluation
Evaluation of the safety profile of medicines is moving from a more reactive approach to a more proactive endeavour with cross-functional teams strategically evolving their understanding of the safety profile of a medicine. This is done by anticipating the benefit-risk profile and its related risk management implications from the start of development. The approach involves addressing sets of questions targeted to further exploring the safety profile of an asset based on its development stage and maturity. The approach involves a collaborative multidisciplinary view via a diverse safety management teams representing relevant cross-functional partners, starts early in the development of a new medicine, and continues into the post-marketing setting. It serves as the basis for any risk management and mitigation activities throughout the lifecycle of a medicine.
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