2nd Annual Risk Management & Pharmacovigilance America Summit

 

SEE THE PAST SPEAKERS & CASE STUDIES
FROM LAST ANNUAL

Annie
TOUGAS
Associate Director, Pharmacovigilance & Medical Information
Ann
STRAUSS
AVP CSRM
Chun-Yuan
GUO
Director, Oncology TA, Medical Safety Office
Tal
KLEINFELD
Sr. Director Head of Global PhV Operation & Regional Manager NA
Tamala Mallett
MOORE
Therapeutic Area Lead in Global Pharmacovigilance and Epidemiology
Susan
WELSH
Chief Safety Officer

 

PAST CASE STUDIES INCLUDE

Chun-Yuan GUODirector, Oncology TA, Medical Safety Office
Janssen

Safety Management Team (SMT) in Risk Management and Pharmacovigilance

This presentation will talk about the safety management team (SMT)’s function in the area of risk management and pharmacovigilance. SMT is recommended by CIOMS to serve as a review and decision-making team in risk management and pharmacovigilance by both under development and marketed drugs. The safety physician serves as an SMT chair and leads all the SMT activities. SMT may include core and extended members. In principle, all major safety issues in risk management and pharmacovigilance should be reviewed/discussed in the SMT.

  • Safety management teams (SMT)’s function in Risk Management and Pharmacovigilance
  • SMT’s structure
  • Common safety issues reviewed/discussed in the SMT
  • SMT’s decision-making process
Ann STRAUSSAVP CSRM
Merck

Safety Review of products from phase 1 through to post-marketing

Understanding the safety profile of a product is important to help ensure the appropriate use and risk minimization. This presentation will focus on the key elements regarding the appropriate safety review of products in development and post-marketing.

  • Key elements of safety review
  • Data to be reviewed, useful tools
  • Pulling it all together
Harry SEIFERTExecutive Director, Clinical Safety Sciences
GlaxoSmithKline Vaccines

Social Listening for Pharmacovigilance

The widespread use of social media and A Pew Foundation study showing that people post and tweet about their healthcare experience, raise questions about how we can use social media for pharmacovigilance the best. What is the value of mining these media for adverse events? What are the potential uses for social media to improve drug safety, both during clinical trials and post-marketing?

  • Social media provide huge volumes of data
  • How can these data be mined for drug safety information?
  • What has been the experience to date?
  • What potential uses for social listening in pharmacovigilance; i.e. what unique values can social listening bring to the table?
Annie TOUGASAssociate Director, Pharmacovigilance & Medical Information
Otsuka Canada Pharmaceutical Inc.

Keeping the Focus: A Local Perspective on Conducting to Day Pharmacovigilance Activities While Managing and Interacting with Multiple Vendors

The outsourcing of pharmacovigilance services at global and local levels is now common practice within pharmaceutical companies. Given that acquisitions and partnerships are also common, todays’ pharmacovigilance systems may include many third-party stakeholders. This presentation will provide:

  • A local perspective where outsourcing of case processing activities is implemented at the local and global levels of the organization and where managing relationships with partners also engaged with different vendors is part of the equation for a successful outcome.
  • Insights on the importance of understanding each other in order to keep the focus on patient safety, sponsor Regulatory responsibilities and compliance
  • Lessons learned in adapting to changes involving Vendor integration

WE ARE LOOKING FORWARD TO WELCOMING YOU ON BOARD IN 2018!

2017 CONFERENCE TOPICS

  • Lessons learned from the risk minimization strategies
  • Function of the Safety Management Teams
  • Safety Review of products in development and post-marketing
  • What are the potential uses for social media to improve drug safety?
  • Vendor management and outsourcing of pharmacovigilance services
  • New definitions in the Maternal Immunization (MI) Pharmacovigilance
  • Risk Management Plans rule amendments
  • Evolving themes for Safety Signal Detection in Clinical Development and post-Marketing
  • New technologies in Pharmacovigilance
  • Benefit-Risk Management

WATCH EVENT VIDEO

DESIGNED FOR

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

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

PRE - CONFERENCE WORKSHOPS

Workshop A

Global harmonization of Pharmacovigilance

  • How should a global RM strategy for a product be implemented in local countries?
  • How to adapt to changes in regulations from worldwide regulators?
  • Understand CIOMS guidelines and methods of implementation by regulators
  • How do different countries deal with multiple different requirements for PV reports?
  • How are various ICH regions working to implement global harmonization practices in the areas of drug safety and risk management?

Workshop B

Risk Management Strategies and Risk Management Plans

  • RMPs rule amendments and its implementation
  • How to measure the effectiveness of RM strategies not only in the US and EU, but worldwide, wherever we market products?
  • What new approaches and priorities should be considered in the Risk Minimization Activities?
  • Main challenges and practical ways to approach safety measures
  • What new approaches and mindset is required given the enhanced regulations?

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