Description

The Pharmacovigilance & Drug Safety event is designed to bring you a unique opportunity to gain fresh insights into the common issues faced in the industry, highlighting the areas with the need to focus on in order to remain compliant. Moreover this conference stream will provide the opportunity to network with various industry professionals including pharmaceuticals, biologics, devices, CROs and PV service providers.

With the augmented incidence of diseases, and the non-medical use of prescription drugs, the incidence of drug abuse has increased enormously in the recent years, which is apparent with the excess documentation of adversities and drug toxicities. In this context, the drug safety and pharmacovigilance has emerged as a dynamic clinical and scientific discipline to provide adequate information and ensure health safety by the joint interaction of doctors and patients in choosing appropriate treatment method and drug.

Pharmacovigilance & Drug Safety event will give you the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs, rather than the cookbook approaches often presented elsewhere. In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements. The summit will provide a platform for the participants to discuss, share and stay updated with present state of affairs in Pharmacovigilance and Drug safety, and contribute to the public health. It will also allow all its participants to interact with the experts, discuss the various developments, challenges faced and innovations in the field.

Key Practical Points

  • Impacts of PV on Covid-19
  • Improving Signal surveillance
  • Artificial Intelligence in Signal Detection
  • Combination products – Regulation, trials, and risk management
  • The role of data mining in Pharmacovigilance and its benefits
  • IDMP standards and strategy
  • Developing a pharmacovigilance risk management plan with a risk minimization action plan (RiskMAP) for high risk products
  • Understanding how Artificial Intelligence is transforming pharmacovigilance
  • Evaluation of quality and manufacturing in production
  • Audits and Inspections
  • Strengthening Pharmacovigilance quality management system
  • Impact of AI in Pharmacovigilance
  • Upcoming regulatory changes
  • Signal management
  • Application of data analytics in Pharmacovigilance processes to increase speed of signal detection
  • Cooperation for patients safety
  • Development and deployment of advanced data management systems
  • Does AI have a real role to play in PV?
  • The role of surveys in controlling the overall risk management system
  • Proactive vs. predictive technologies in the future of PV
  • Brexit and the impact on pharmacovigilance
  • Strategies to improve PV
  • Real World Evidence in PV
  • Best practices for developing an overall PV audit strategy with a business partner
  • Is there a way to effectively and reliably use social media towards a QPPV’s end goals?
  • Real-time drug safety data analysis in medical monitoring
  • How has inspection preparation changed and what are the new methods on the horizon?
  • Big data and AI in pharmacovigilance
  • Pharmacovigilance Monitoring and automation in Social media

Who should attend?

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical/biotechnology industry / industries involved in:

  • QPPV
  • Risk Management
  • Pharmacoepidemiology
  • Signal Detection
  • Pharmacovigilance
  • Risk Assessment
  • Market Research Programs
  • PV Governance
  • Phase IV/Postmarketing Safety
  • Drug Safety
  • Patient Safety
  • Medical Affairs
  • Quality Assurance
  • Regulatory Affairs
  • Audit Readiness
  • Medical Safety
  • Safety Surveillance

Keynote Speakers

Slide FEATURED Mircea
Ciuca
Mircea Ciuca, MD is currently Global Therapeutic Area Head (Respiratory & Transplant) in Clinical Safety and Pharmacovigilance department at CSL Behring. He is leading a team of safety physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings. GLOBAL THERAPEUTIC AREA HEAD - GLOBAL CLINICAL SAFETY AND PHARMACOVIGILANCE AT CSL BEHRING
Slide FEATURED Susana
Almeida
Dr. Susana Almeida is Clinical Development and Safety Director at Medicines for Europe (formerly EGA). Before joining Medicines for Europe, Susana was the Chair of the Association’s Bioequivalence Working Group for almost 15 years. CLINICAL DEVELOPMENT AND SAFETY DIRECTOR AT MEDICINES FOR EUROPE
Slide FEATURED Robert
Weber
Robert Weber is Product Management Director in the Oracle Heath Sciences Global Business Unit. His responsibilities include the Empirica Signal Detection and Management products in the Oracle Pharmacovigilance suite. PRODUCT MANAGEMENT DIRECTOR AT ORACLE
Slide FEATURED Marie-Laure
Kürzinger
Marie-Laure Kürzinger has more than 20 years of experience in Epidemiology. Before joining the pharma industry, Marie-Laure worked in academia where she developed field epidemiology expertise. BENEFIT-RISK EXPERT, GLOBAL PHARMACOVIGILANCE AT SANOFI
View all speakers

Exhibitors & Sponsors

Booth #H3

IMP Logistics

Slide BIOTECH PHARMA SUMMIT - PORTO / 2021 REGISTER NOW