June 14th–15th, 2018

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

·       Assurance & Compliance
·       Quality Assurance
·       Quality Control
·       Data Analysis
·       Pharmacovigilance
·       Pharmacology
·       Pharmacoepidemiology
·       Epidemiology
·       Medical Information
·       Health Outcomes
·       PSUR/PBRER
·       Clinical Data Management
·       MedDRA
·       PV Agreements
·       PASS/PAES
·       PSMF
·       CAPA
·       QPPVQPPV
·       Medical Affairs
·       Adverse Drug Reactions
·       Drug/Product Safety
·       Drug Development
·       RMPs
·       GPvP
·       ICH-GCP
·       Clinical Pharmacology
·       Clinical Safety
·       Clinical Trials
·       Clinical Trial Management
·       Clinical Development
·       Clinical Research
·       Risk Management
·       Research & Development
·       Patient Safety
·       Signal Detection
·       Signal Management
·       Safety Surveillance
·       Safety Databases
·       Safety Evaluation
·       Outcome Research
·       Regulatory Affairs and Compliance
·       Data management and data mining
·       Benefit-Risk Assessment
·       Regulatory Submissions
·       PV Governance
·       Safety Management
·       Pharmacovigilance Operations
·       PV Inspection and Audit Readiness
·       Patient Support Programs
·       Medical Safety
·       Medical Product Safety Assessment
·       Phase IV/Postmarketing Safety

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

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Event Schedule
Event Speakers
Day 1 :
8:20 Registration and Welcome Coffee
8:10 Opening Address from the Chairperson
9:00 Case Study | Will stricter drug safety regulation lead to safer drugs?
9:40 Speed Networking
10:20 Case Study | New PV legislation in Ukraine
11:00 Morning Coffee and Networking Break
11:30 Case Study | Developing a pharmacovigilance risk management plan with a risk minimization action plan (RiskMAP) for high risk products
12:10 Case Study | Minimizing ADRs by including the patient as one pillar of the therapeutic plan
12:50 Business Lunch
13:50 Case Study | Being ready for an inspection of your pharmacovigilance system
14:30 Case Study | Pharmacovigilance System Master File and Regulatory Inspections expectations
15:10 Afternoon Coffee and Networking Break
15:40 Case Study | Pharmacovigilance System Master File (PSMF) – Audits and Inspections
16:20 Case Study | New trends in inspections of the RMP, signal detection, post-authorisation safety studies (PASS) and internal audit
17:00 Case Study | What GVP auditors currently focus on?
17:40 Panel Discussion| Communicating the Risk in Pharmacovigilance: Are We Going in the Right Direction?
18:20 Chairman’s Closing Remarks and End of Day 1
18:30 Evening drinks Reception
Day 2 :
Event expired, so you can buy ticket at the moment.