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3RD ANNUAL RISK MANAGEMENT AND PHARMACOVIGILANCE AMERICA SUMMIT

23 -25 OCTOBER 2018, BOSTON
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PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

Andrea
BEST

Executive Medical Director, Pharmacovigilance and Patient Safety

Patricia
FLEURANCEAU-MOREL

Senior Director – Head of Pharmacovigilance Scientists (Billerica) - Global Patient Safety

Sandra
RAFF

Senior Director, Global Drug Safety

Kevin
LEARY

Director, Clinical Safety and Risk Management

Bruno
MENDEZ

Global Head Quality Pharmacovigilance

Anand ANANTHAKRISHNAN

Digital Platform Leader

CONFERENCE TOPICS 2018

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • The interface of digital medicine and drug safety
  • Navigating the complexities of Reference Safety Information (RSI) in the clinical trial setting
  • Immune-Related Adverse Events in oncology
  • Artificial Intelligence and Machine Learning in drug safety
  • How to develop an overall business partner PV audit strategy?
  • New challenges in global safety governance
  • Building a drug safety department
  • Benefit-risk assessment and patient centricity in drug safetyEmerging new technologies in PV

DESIGNED FOR

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

  • Pharmacovigilance
  • Drug Safety
  • Safety & Risk Management
  • Signal Detection
  • Benefit-Risk Assessment
  • Safety Evaluation
  • Regulatory Affairs, Pharmacovigilance
  • PV Governance
  • Quality Pharmacovigilance
  • Safety Surveillance
  • Pharmacovigilance Operations
  • PV Inspection and Audit Readiness
  • Patient Support Programs
  • Market Research Programs
  • Clinical Safety
  • Medical Safety
  • Medical Information

CASE STUDIES

PAST CASE STUDIES INCLUDE

CASE STUDY / DAY 1

How Does Digital Medicine Impact Pharmacovigilance?

The reality and potential reality of digital medicine has become a vast enterprise. The challenges of integrating safety data from traditional sources and new sources of data from big data and from digital medical treatment modalities, and the challenges of presenting and assessing this digital medicine safety data will be discussed.

  • What is digital medicine?
  • What is the scope of digital medicine?
  • What are the potential vectors of data from digital medicine that may impact pharmacovigilance?
  • What are the challenges for managing the types of data from digital medicine to make sound pharmacovigilance and risk benefit assessments and decisions for drugs and devices?

Sandra
RAFF

Senior Director, Global Drug Safety

Kevin
LEARY

Director, Clinical Safety and Risk Management

CASE STUDY / DAY 1

Immune-Related Adverse Events in oncology: Challenges in Detection, Surveillance and Risk Communication

Over the last 20 years, immunotherapy has fundamentally changed the treatment paradigm for many malignancies. The toxicity profile of these agents introduces specific challenges to the pharmaceutical industry, regulators, investigators, clinicians, and patients. With a focus on immune checkpoint inhibitors, this presentation will address the challenges associated with detection, surveillance and risk communication associated with immunotherapy in the oncology population.

  • Immunotherapy has fundamentally changed the treatment paradigm for cancer
  • The novel toxicity profile of immunotherapy presents unique challenges to risk management and pharmacovigilance
  • Detection of ADRs, safety surveillance and risk communication within immune-oncology will be addressed
  • Immune checkpoint inhibitors will be utilized to provide examples

CASE STUDY / DAY 2

Cutting costs with intelligent automation

With the advent of new technologies and awesome computing power, there are certainly efficiencies to be gained. In this presentation I will cover how to do more with less, using automation.

  • Emerging new technologies in PV
  • Automation of routine work
  • Cost savings and efficiency gains

Anand
ANANTHAKRISHNAN

Director, PV Safety System and Operations

Bruno
MENDEZ

Global Head Quality Pharmacovigilance

CASE STUDY / DAY 2

Pharmacovigilance Business Partner Audit Program

Pharmaceutical companies have thousands of business partners for which in many situations a dedicated Pharmacovigilance agreement has to be in place. But how do we ensure the compliance of the PV agreements?

  • Develop an overall business partner PV audit strategy
  • Use a risk-based approach to define a business partners audit program
  • Identifying and categorizing your audit pool
  • Analyze the assessment and resulting audit plan
  • Discuss the resources needed to perform audits
  • Incorporate alternatives to control risk, such as use of surveys

SPONSOR 2018

A SPECIAL THANK YOU TO OUR SPONSOR

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