Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference

March 12-13, 2019 | Alexandria, VA

Sheraton Suites Old Town Alexandria

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DAY TWO | WEDNESDAY, MARCH 13TH

8:30 REGISTRATION & WELCOME COFFEE

8:55 CHAIRPERSON’S OPENING REMARKS
Alexandre Kiazand, ASTRAZENECA

9:00 COMPLIANCE: POST-MARKET APPROACHES TO DRUG SAFETY FROM ADVERSE EVENT REPORTING TO MANDATED STUDIES
The primary mandate of the US FDA is to ensure marketed medicinal products are safe and effective for intended users, a mandate which extends well past initial product clearance into the post-market, real-world setting. To ensure adverse events are reviewed and handled in the most effective manner, the agency utilizes a variety of tools, from advanced data mining to establish causal relationships in potential safety signals, to collaboration with clinical pharmacologists to review chemical compounds. As some new products will be required to conduct formal post-market clinical research to further establish the long-term safety, it is important for industry to understand the path which leads to those decisions being made.

  • Agency initiatives and research surrounding post-market safety
  • Methods used to determine causal relationship to safety event
  • Paths to FDA mandated post-market clinical safety studies

Anne Walsh, Director, HYMAN, PHELPS, & MCNAMARA

 

9:45 INCREASING EFFICIENCIES AND STREAMLINE OPERATIONS WITH DRUG SAFETY CROSS-FUNCTIONAL TEAMS AND VENDORS

  • Strategies for liaising with partners within vendors and internal teams
  • Improved efficiency, oversight, and reduced paperwork burden
  • Eliminated redundant reporting which lead to significant cost savings
  • Lesson learned working on 30+ clinical trials with 5 vendors

Zeba Nabizada, Associate Director, Clinical PV Collaboration and Vendor Management, PHARMACYCLICS

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 PANEL: TRANSFORMING DRUG SAFETY FROM NATIONAL TO A GLOBAL SAFETY SURVEILLANCE MECHANISM

  • Centralized vs. decentralized models of safety monitoring
  • Aligning safety reporting formats, timelines & technology
  • Impact of industry M&A on global safety monitoring

MODERATOR:
Alexandre Kiazand, ASTRAZENECA

PANELISTS:
Zeba Nabizada, PHARMACYCLICS

Michael Sauders, ARRAY BIOPHARM

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

 

1:30 – 4:00 UTILIZATION OF REAL WORLD DATA IN DRUG SAFETY MODULE

1:30 USE OF REAL WORLD DATA AND POST-MARKET STUDIES TO SUPPORT LONG-TERM SAFETY
Real world outcomes data provides manufacturers with a tremendous level of incoming safety and effectiveness data, which can lead to the early detection of potential safety issues as well as providing insights into actualized prescribing and utilization patterns. Of particular concern to many drug safety teams is ensuring long-term safety, which can be monitored through a number of platforms and methods including patient databases, registries and analysis of incoming adverse event reports. Through the use of multiple channels including data mining of social media, pharmaceutical and biotechnology corporations can gain valuable and proactive insights, identifying signals at the earliest possible point.

Tzuyung Douglas Kou, Immunoscience Epidemiology Lead, Operational Chair of Risk Management Strategy Committee
BRISTOL-MYERS SQUIBB

 

2:15 GROUP DISCUSSION: ELEVATING THE USE OF REAL WORLD DATA IN SIGNAL DETECTION

FACILITATOR:
Michael Saunders, Executive Director, Drug Safety & Pharmacovigilance, ARRAY BIOPHARMA

 

3:00 COMPLIANCE: VALUE OF REAL WORLD EVIDENCE IN MAINTAINING POST-MARKET SAFETY

  • Validating real-world outcomes & observations
  • Best practices in conducting observational studies
  • Generating product insights for wider patient bases

Marc J. Scheineson, Esq., Partner, ALSTON & BIRD LLP

 

3:45 CLOSING REMARKS AND CONCLUSION OF CONFERENCE PROGRAM