SELECTED CASE STUDIES
Selected Case Studies from the Agenda
Chun-Yuan GUODirector, Oncology TA, Medical Safety Office
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
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
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