Fierce Drug Safety Summit Clinical Trials Lab

What to expect at the Fierce Drug Safety Summit...

The Fierce Drug Safety Summit (also known as the REMS Summit) is a virtual event that  will allow pharma, biotechs, and device companies to learn how to better perform their drug safety processes. Leaders in pharmacovigilance, drug safety, risk management, and regulatory will discuss the most effective ways to institute a successful Drug Safety program, and be better equipped to meet government regulations, ensuring the safety of patients.

Top Reasons to Attend

  • Regulatory Updates - Hear updates from the FDA on new guidances passed

  • Learn How to Plan - Understand how to develop a global risk management plan ensuring compliance across regions

  • Stay Ahead of Current Trends - Learn how to navigate the current changing landscape of REMS and Pharmacovigilance management

  • Technology Updates - Learn how to properly incorporate AI and machine learning technology into PV operations to enhance practices and cut costs

  • Networking Opportunities - Connect with Heads of REMS and PV operations to gain insights and best practices on daily challenges faced within these fields

Major Themes

Risk Evaluation and Mitigation Strategies

Health Literacy

Health Literacy

Health Literacy in Risk Evaluation and Mitigation Strategies

Patient Engagement

Patient Engagement

Patient engagement within Risk Evaluation and Mitigation Strategies

FDA Updates

FDA Updates

New FDA updates and guidance for REMS operations

Therapeutic Applications

Therapeutic Applications

Discussions on how REMS is used in specific therapeutic areas and why they are necessary

Pharmacovigilance

Global PV

Global PV

Global PV- current pharmacovigilance operations and updates on a cross-regional scope

Risk Management

Risk Management

Risk management- how drug safety teams plan for adverse effects before they are reported

Data Procurement

Data Procurement

Discussions on current technological advancements within data procurement and analysis

FDA Guidance

FDA Guidance

Discussions on new FDA guidance and updates in PV
Fierce Cell and Gene Therapy Sponsoships

Questex experiences bring people together and drive businesses forward...

Through event and digital experiences, Questex helps audiences discover new ways to expand and optimize their businesses, learn the ins and outs of unique solutions, and find the right providers when they are ready to buy. We are the trusted partner that most companies rely on to stay updated on current trends, to understand the new and innovative technologies and solutions, to benchmark against other similar companies, and to catch up with their peers and like-minded colleagues.

Fierce Drug Safety Summit Partner Content Hub

This hub provides access to on-demand sessions, partner videos, webinars, and research in a virtual environment that is easy to navigate, learn from, and share with peers and colleagues.

Content