1. DIA Clinical Safety and Pharmacovigilance Community
Community Call 09 February 2017
Catherine Baldridge, MS and Beth Garrard, PharmD
DIA CSP Co-Chairs

2. Today’s Agenda Time Topic Presenter(s) 8:00 AM EST
CSP Community Mission Statement & Goals
Catherine & Beth
8:10 AM EST
January PV Conference Re-cap
Beth
8:30 AM EST
DIA TIRS PV Article Review
All
8:40 AM EST
Proposed Agenda
Catherine/Beth
8:50 AM EST
ASA Biopharms Safety Monitoring Working Group
Susan Duke
8:55 AM EST
Core Leadership Roles & Goals
Core Leadership Team
Open Forum

3. DIA CSP Community Call 09-Feb-2017
CSP Community Mission Statement
“Our mission is to provide a collaborative environment designed to provide a forum to help foster best practices, new ideas, and discuss the changing regulatory environment as it relates to Clinical Safety & Pharmacovigilance (CSP) in order to enhance the practice of monitoring the safety of drugs, biologics, and devices in the interest of public health.
Our members are professionals working in any aspect of the CSP realm and use this global forum to share, evaluate, and disseminate information on processes, standards, and technologies for the management of safety and pharmacovigilance data”.

4. DIA CSP Community Call 09-Feb-2017
CSP Community Mission Goals
Goals
Streamline Community Calls and Organization
Education
Provide educational topics/speakers
Request for Topics
Output
Publish Articles, White Papers, Opinion pieces and recommendations for process documents
Establish/Join Scientific Working Groups
Global Open Forum

5. DIA CSP Community Call 09-Feb-2017
CSP Core Team Logistics and Announcements
Core Team will meet Monthly on first Thursday of each month (confirm time)
Community Calls will be held Monthly on second Thursday of each month (confirm time)
CSP is featured in the spotlight in DIA Global Forum – check it out!
Our thanks to Maral for providing Core Team Training!

6. CSP Community Spotlight!!!!

7. DIA CSP Community Call 09-Feb-2017
January 2017 Safety/PV Conference Recap
January , 2017
Mandarin Oriental Washington D.C.

8. DIA Clinical Safety and Pharmacovigilance Community
Pharmacovigilance and Risk Management Strategies Annual Meeting
Recap
09Feb2017

9. Conference Highlights
Global Regulatory Safety Updates
The Future of Pharmacovigilance
Luncheon Round Table Discussions with Key Thought Leaders
Special Hot Topic Panels and Debates
27 Exhibiting Companies
Networking Opportunities
Short Course Offerings on Sunday, January 22

10. The 2017 program focused on:
Conference 2017 Focus
The 2017 program focused on:
Cutting edge innovation across the entire life cycle of biopharmaceutical products
New therapeutic approaches to diseases that change patients’ lives,
Enlightened evolution of regulatory science that speeds needed products to prescribers and patients, and,
Most importantly, engagement of patients in the product development and regulatory processes. 

11. Today’s Agenda
Agenda: 
Short courses
Day 1
Day 2
Day 3   

12. Short Courses
FDA Adverse Event Reporting System (FAERS: Individual Case Safety Reports (ICSR) and Data Quality
Pharmacovigilance and Risk Management Planning
ICH E2C (R2); The Quantum Leap[ from PSURs to Benefit-Risk Evaluation Reports (PBRERs); Background, Expectations and Practicalities
FDA Pharmacovigilance Inspection Readiness

13. Day 1 -
Keynote Address
Innovative Therapies, Processes and the Growing Role for Pharmacovigilance
Hans-Georg Eichler – Sr. Medical Officer – EMA
Adaptive Biomedical Innovation (API): Evolving our Global System to Sustainably and Safely bring new Medicines to Patients in Need.

14. ABI – Key Stakeholders

15. Day 1 FDA Updates Changing Environments Safety Data rEvolution
Integrated Adaptive Development and Decision Making

16. Day 2 EU Regulatory Updates Globalization of the Responsible Person
Advances in Benefit Risk
Engaging the Customer – Healthcare providers

17. Day 3
Advanced Therapies
Advanced Technologies
Hot Topic Panel

18. Learning Objectives
At the conclusion of this conference, participants should be able to:
Employ the current regulatory framework for pharmacovigilance in key markets, including the US and EU
Examine the influence of recent regulatory developments and expectations in Japan, China, and Mexico on safety and pharmacovigilance practice
Discuss how advanced therapies and technologies may impact pharmacovigilance and risk management
Discuss how the needs for access to innovative medicines and for safety information can be balanced during the application of new adaptive development pathways
Describe considerations for appraising the value of data sources outside the spontaneous reporting system for safety and benefit-risk assessments
Utilize new approaches for presentation of benefit-risk data and communication of risk-benefit messages to health care providers, patients, and consumers

20. DIA CSP Community Call 09-Feb-2017
DIA TIRS PV Article Review #1
Can Pharmacovigilance Learn from the Oil and Gas Industry, Which Has Been Outsourcing for Over a Century?
Abstract: Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for initiating as well as maintaining an outsource relationship. In this paper, the authors propose that the sector can learn from other industries that have been outsourcing activities for a much longer time, such as the oil and gas industry. The Safety Case is put forward as a body of evidence that facilitates the continuous exchange of data, especially focused on risk management of the relationship between outsourcer and vendor. Finally, the authors will make an attempt to come to a global consensus in this area through the Allliance for Clinical Research Excellence and Safety (ACRES) network
Companies that want to outsource PV activities should consider their own role in the activities beforehand
Vendors should be prepared to create and maintain a valid Safety Case including a risk assessment matrix that they are prepared to share with the outsourcer
Companies that want to outsource PV Activities should consistently ask for a Safety Case to be presented together with the response to a request for proposal.
The Safety Case should be kept up-to-date

21. DIA CSP Community Call 09-Feb-2017
DIA TIRS PV Article Review #2
Social Medio Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape
Abstract: In the context of the European Union’s Innovative Medicines Initiative (IMI) project titled Web-Recognizing Adverse Drug Reactions (WEB-RADR; which focuses on the assessment of new data sources and the optimization of the collection of information on suspected adverse reactions in pharmacovigilance, a survey was performed in 182 countries/ jurisdictions in 2014 to The goal was to gather information on existing practices, guidance, and legal requirements on social media monitoring to identify potential safety issues related to medicines. The survey response rate was 100%. The results revealed that 80% of the surveyed countries do not have such necessities despite the fact that 63% of these countries have an established national pharmacovigilance system. Among the countries having an established pharmacovigilance system, only 29% have specific requirements, most countries do have similar provisions as set out in the EU guidelines on Good Pharmacovigilance Practices (GVP). A small subset of countries within the European Economic Area (EEA) have requirements that exceed those stated in GVP, namely, Italy, France, Sweden, and the UK. Outside the EEA, Turkey and the United States have also developed further guidance. The outcome of the survey will inform the development of a future policy framework on the further use of social media as new pharmacovigilance data source in the EEA. In addition, this paper elaborates on some current practical case management issues encountered by companies based on the existing regulatory guidance
Discussion points: Identifiable Reporter/Patient, Follow-up of Potential ADRs, Day Zero, Tracking of Non-Valid reports, Spontaneous vs Solicited Reports, & Transparency
The survey performed as part of the WEB-RADR project has shown that in many countries, guidance for ADR reporting in the context of social media is established, thus highlighting the important of this data source for PV.
Practical experience revealed that there are areas that need to be further addressed or clarified to ensure MAHs put adequate procedures in place to meet their safety reporting/monitoring obligations.

22. DIA CSP Community Call 09-Feb-2017
CSP Community Proposed Agenda
MedDRA
MedDRA Back-to-Basics Webinar
Biosimilars labeling/coding
FDA proposed change to reporting from LLT in 2018
Medication Errors vs Product Complaints
Safety & Pharmacovigilance Education
Undergraduate, Graduate, and Certificate Programs and Opportunities
Regulatory Training via FDA & EMA
FDA guidance Safety Assessment Committees
BREXIT & PV Impact
Proposed rule FDA-2013-N-0500 – Generic Labeling in July 2016
ICH E19 Review
Pharmacovigilance Outsourcing (Annette Williams article in the Forum this month)
Changes in Safety & PV regulations –now and upcoming
Final Rule – PM Safety Reporting for Combination products, published Dec 20, 2016
Final Guidance – Public Notification of Emerging Postmarket Medical Device Signals – published Dec 14th, 2016
ICH Integrated Addendum to ICH E6 (R1), Clinical Practice (GCP) E6 (R2) – ICH adopted final guideline on Nov 9th, 2016
2017 DIA Annual Meeting Highlights
Other topics?

23. DIA CSP Community Call 09-Feb-2017
ASA Biopharms Safety Monitoring Working Group
Brief Description
Request for 2-3 individuals interested in joining group
PV CSP Community Contact:
Susan Duke –

24. DIA CSP Community Call 09-Feb-2017
Core Community Leadership Team
Beth Garrard, US
DIA CSP Co-Chair
Catherine Baldridge, US
DIA CSP Co-Chair
The Co-Chairs work with the Core Committee to develop the Community objectives and the governance structure of the Community, while ensuring a maximum level of Community activity to maintain Community status.

25. DIA CSP Community Call 09-Feb-2017
Core Community Leadership Team
Jill Notte, US
Communications Coordinator
Develop and maintain a system for informing Community members of activities and relevant information.
Act as administrator for DIA Community website: keep the site clean, keep content up to date, keep access accurate.
Use communications to help coordinate and ensure delivery of action items and associated deliverables.
Help committee chairs with communication and site activity (eg, posting agendas and minutes), as needed.

26. DIA CSP Community Call 09-Feb-2017
Core Community Leadership Team
Cristina Parau, GB
Education Coordinator
Lead the development of a schedule for Community Webinars, Teleconferences, and Education related Documents and Guides.
Coordinate with Speakers and Presenters to schedule webinars and teleconferences and ensure that presentation materials are available before the scheduled event.
Announce educational events using the Communities Platform and create “Events” for downloading.

27. DIA CSP Community Call 09-Feb-2017
Pierre-Yves De Zeeuw, DE
Program Coordinator
Encourage and facilitate member participation in abstract submission for DIA meetings.
Keep the Core Committee and Community Members updated on upcoming DIA events that are relevant to Community members.
Coordinate with the Program Committee members of specific meetings to communicate Community needs and suggestions for upcoming meeting programing.
Core Community Leadership Team

28. DIA CSP Community Call 09-Feb-2017
Teiki Iwaoka, JP
Member Engagement
Working with the Core Committee and DIA staff, coordinate the development of opportunities for members to share their expertise through large, small and micro-projects.
Identify working group needs and coordinate with Working Group leaders to develop projects, guidance and best-practice documents, and otherwise encourage member engagement.
Work closely with the Communications Coordinator to gauge Community member participation and solicit feedback on Community activities.

29. DIA CSP Community Call 09-Feb-2017
Open Forum