Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference

March 12-13, 2019 | Alexandria, VA

Sheraton Suites Old Town Alexandria

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DAY ONE | TUESDAY, MARCH 12TH

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Alexandre Kiazand, Global Head of Safety Sciences, ASTRAZENECA

9:00 OPENING ICE BREAKER: DRUG SAFETY & PHARMACOVIGILANCE OPERATIONS FOR EXECUTIVE LEVEL AUDIENCE
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives on the daily challenges of executive level audiences, discussing challenges associate with risk-based signal detection processes, feedback from regulatory authority interactions, and global considerations for pharmacovigilance activities and reporting. Furthermore, participants in this warm-up session are also given the op-portunity to directly build contacts.

 

9:30 CASE STUDY: RISK BASED APPROACHES TO SIGNAL DETECTION & SAFETY SURVEILLANCE
At the heart of drug safety monitoring is delivering a predictive and proactive system, which provides the early identification of safety signals so that action can be taken to maintain the safety and health of patients. Reducing risks of regulatory intervention and potential label revisions, the integration of signal detection from the earliest stages of product development is of essential importance. Exploring one organization’s journey in the development of a highly sophisticated signal detection system which has reduced risks and heightened awareness to potential adverse events will provide insights into optimized best practices.

  • Utilizing software to optimize safety signal detection
  • Effective, risk-based signal algorithm development
  • Ensuring data is accurate and representative
  • Proactive measures in reporting & label changes

Ken Hornbuckle, Research Fellow – Pharmacoepidemiology, Global Patient Safety
ELI LILLY AND COMPANY

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 SMALL GROUP DISCUSSION: SUPPORTING REGULATORY CLEARANCE THROUGH PROACTIVE DRUG SAFETY IN CLINICAL RESEARCH
Demonstrating the safety of a new medicinal product is of primary importance during clinical research, requiring continuous, proactive and predictive monitoring of study outcomes throughout research phases to identify potential risks. From the integration of technology to more accurately gather and document patient outcomes data, to traditional methods of study monitoring, executives must ensure the robust collection and analysis of data to support regulatory requirements. This foundation of the product lifecycle, rooted in safety, will not only more efficiently support product clearance, but will also set the stage for successful long-term monitoring of products to ensure patient wellbeing throughout the lifecycle.

LEARNING OBJECTIVES:

  • Progressive drug safety in study phases
  • Dossier preparation for approval submission
  • Pivoting pre-approval safety into monitoring

FACILITATOR: Alexandre Kiazand, Global Head of Safety Sciences, ASTRAZENECA

 

11:45 GROUP DISCUSSION: NAVIGATING SUCCESSFUL DRUG SAFETY REGULATORY AUDITS
Paula Markos, Associate Director, R&D Quality, Inspection Management, ABBVIE

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

 

1:45 – 3:15 SAFETY RELATED REGULATORY AUDITS & INSPECTIONS MODULE

1:45 COMMON INSPECTION OBSERVATIONS AS RELATED TO DRUG SAFETY MONITORING & DOCUMENTATION

  • Internal procedures for surveillance including
    • Spontaneous adverse events
    • Solicited reporting of events
    • Internet & literature observations
  • Conduct & handling of adverse event receipt
  • Evaluation & follow-up on adverse events reported
  • Timelines for expedited, non-expedited & aggregated reports

Lowell Zeta, Senior Associate, HOGAN LOVELLS

 

2:30 FLEXION CASE STUDY: BEST PRACTICES IN PREPARING FOR DRUG SAFETY RELATED INSPECTIONS
Jennifer Kane, Head of Pharmacovigilance, FLEXION THERAPEUTICS

 

3:15 COFFEE AND NETWORKING BREAK

 

3:45 REGULATORY CONSIDERATIONS FOR DRUG SAFETY IN THE MIDDLE EAST AND NORTH AFRICA
Danya Qato, PhD, PharmD, MPH, Assistant Professor of Pharmaceutical Health Services Research
UNIVERSITY OF MARYLAND

 

4:30 GROUP DISCUSSION: ADDRESSING COMPLEXITIES OF PHARMACOVIGILANCE PROCESS IN GLOBAL MARKETS
As manufacturers continue to expand the global reach of medical device products, the continued surveillance of products grows in complexity as drug safety executives look to ensure compliance with all regional expectations and compliance standards for pharmacovigilance monitoring. Open group discussions will provide participants with an opportunity to delve into unique markets where pharmacovigilance and drug safety operations are proving difficult, ensuring knowledge is gathered on regions of most concern.

GROUP ONE: ASIA-PACIFIC REGION

GROUP TWO: EU REGION

 

5:30 END OF DAY ONE CONFERENCE