Karsten Lollike
Corporate VP and QPPV, Global Safety
Novo Nordisk A/S
14 — 15 June, 2018 Berlin
The event has already occured.
The stringent regulations on safety monitoring increased the safety in data collection, analysis and regulatory surveillance. Adding to this the rising demand for drugs, the amplified need for novel therapeutics development via extensive clinical trials and the world population growth made drug manufacturers start paying more attention to Pharmacovigilance as public anxiety about safety increases.
Furthermore, the growth of exponential rare and chronic diseases contributed to an increased need for drug development, therefore this led the industry to have a bigger focus on drug safety.
On this B2B event, participants will have the chance to learn more about this challenging era and the latest developments in Pharmacovigilance and Drug Safety with the main key players in this field.
This event will be focusing on trends on Regulatory challenges, Signal detection, Data management, Risk management, Audit & Inspection and New technology applied to Pharmacovigilance procedures.
We invite you to discuss and debate these challenges in a dialogue amongst top professionals in Pharmacovigilance.
– Using Real-Word data from social media and other sources for signal detection
– Managing diverse data sets and applying advanced analytical and statistical modelling techniques
– Cloud-Based reporting to bring a robust global database of ADRs
– Automation of adverse events reporting and artificial intelligence application
– Applying data analytics in Pharmacovigilance processes to increase the speed of signal detection
– Making sure your operations are aligned with the FDA’s current thinking on data integrity
– QPPV Update: EudraVigilance (EV) – The new EV System
– EMA’s WEB-RADR and the FDA’s sentinel initiative
– Impact of personalized medicine on pharmacovigilance
– Outsourcing to increase efficiency and cut your costs – The benefits and challenges
– Artificial intelligence to turn PVO into a predictive science
– Comply with FDA’s June 2018 deadline for combination product safety reporting
– Being ready for an inspection of your pharmacovigilance system
– Benefit-Risk Evaluations: The patient perspective
– Overcoming the timeline challenges in communicating rapidly with Market Authorisation Holders
– Implementing global harmonization practices in the areas of drug safety and risk management
– Minimizing ADRs by including the patient as one pillar of the therapeutic plan
Corporate VP and QPPV, Global Safety
Novo Nordisk A/S
Business Developer EMEA
AB-Cube
Country Head - Patient Safety
Novartis
Associate Director, Global Pharmacovigilance Governance, Head Pharmacovigilance Quality System
Mylan
Head of Pharmacovigilance Italy
Mylan
Director, Compliance & Business Management Global Pharmacovigilance
Otsuka
PV Leader
IBM
Director Global Pharmacovigilance
Oracle Health Sciences Consulting
Associate Director
AbbVie
Pharmacovigilance Officer and Expert Toxicologist
Ferrer International
PPhv Scientist and Director
NC Vigilance Ltd
Senior Manager - Regional PV, Vendor Management, Training and Compliance
Cipla
Head of Department of Standards and Certification
Polish Society of Pharmacovigilance
Director of Medical and Regulatory Affairs Department
Acino Pharma
CEO
Quartica
The Conference will be taking place at Crowne Plaza Berlin City Centre
Nürnberger Str. 65, 10787 Berlin, Germany
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