PHARMACOVIGILANCE & DRUG SAFETY SUMMIT FORUM

Addressing up-to-date Regulatory changes, Signal Detection and New Tech trends

Conference overview

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.

Key Topics

–        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

Who Should Be Attending

Target Audience

–        International and regional health authorities and regulators
–        Pharmaceutical, Vaccines, & Biotechnology companies
–        Clinical Research Organization (CRO) service providers
–        Business Process Outsourcing (BPO) service providers
–        Risk Management Software developers
–        Pharmacovigilance Audit Firm’s
–        Pharmacovigilance consultancy service providers
–        Contract Research Organizations
–        Adverse Event/Case Management Service Providers
–        Safety Database Providers for Case Management
–        Healthcare/Pharmacovigilance Consultants
–        Healthcare Translation Agencies
–        Technology Vendors/Portal Service Providers

Aluminium Sponsor

Silver Sponsor

Event Gallery

For any enquiry on regards to special offers & group discounts please contact us directly at:
info@globalbsg.com