DIA Clinical Safety and Pharmacovigilance Community All Hands Meeting 09 November 2016

Today’s Agenda Agenda: Touch-Base 2016 Recap What we've been up to & What’s next January 2017 Safety/PV Conference in DC Update CSP Community Let’s look around Request for Volunteers Next Topics & Training Opportunities Open Forum

DIA CSP AHM 09-Nov-2016 2016 Community Recap February Request to re-engage Chair & Co-chair developed based on interest and feedback May 2016 Revival Meeting Request for Community leaders unanswered Aug 2016 AHM Meeting Annual Conference Recap Request for speakers Brexit & the Pharma Impact

DIA CSP AHM 09-Nov-2016 2016 Community Revival attempts Catherine Beth CSP Community page updates & information Attempts to re-engage community We’ll talk about this later  Beth Member of 2017 PV & Risk Management Strategies Conference Program Committee Working to bring new and exciting topics to this years conference

2017 PV & Risk Management Strategies Conference DIA CSP AHM 09-Nov-2016 2017 PV & Risk Management Strategies Conference Planning the program Who should attend? Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in: Drug Safety/Pharmacovigilance Risk Management, including Risk Evaluation and Mitigation Strategies (REMS) Benefit-risk assessment and communication Medical Product Safety Assessment Regulatory Affairs Clinical Research Pharmacoepidemiology Post-market studies and Real World Evidence generation Customer Engagement Programs, including Patient Support Programs Medical Information, Medical Communications Health Outcomes

2017 PV & Risk Management Strategies Conference DIA CSP AHM 09-Nov-2016 2017 PV & Risk Management Strategies Conference

2017 PV & Risk Management Strategies Conference DIA CSP AHM 09-Nov-2016 2017 PV & Risk Management Strategies Conference

2017 PV & Risk Management Strategies Conference DIA CSP AHM 09-Nov-2016 2017 PV & Risk Management Strategies Conference Message from Co-Chair Beth Garrard on why you should attend We’ll be there! Will you?

DIA CSP AHM 09-Nov-2016 Did you know… The Clinical Safety & PV Community has THE 2nd HIGHEST community members of DIA! Regulatory Affairs has 595 Clinical Safety & PV has 386 Clinical Research Community has 378 Good Clinical Practices & Quality Assurance Community has 335

DIA CSP AHM 09-Nov-2016 Our Community Page & Activity Are you reading? What topics are you interested in? Is there an EU or other member of the community willing to post for and update on other global trends?

DIA CSP AHM 09-Nov-2016 Our Community Page & Activity Lets go Look!

DIA CSP AHM 09-Nov-2016 CSP Community Leaders – Volunteer Opportunity Attempts to further engage in the community Based on May 2016 poll results

Slide from May 2016 DIA CSP AHM 09-Nov-2016 Question 4 – Why did you engage in the DIA CSP Community? “To share and get insights on best practices and experience” “Share opinions on new regulations and operational practices to implement” Slide from May 2016

Slide from May 2016 DIA CSP AHM 09-Nov-2016 Question 7 – I am interested in becoming the DIA CSP Community Leader... Slide from May 2016

CSP Community Leaders – Volunteer Opportunity DIA CSP AHM 09-Nov-2016 CSP Community Leaders – Volunteer Opportunity

DIA CSP AHM 09-Nov-2016 CSP Community Leaders – Volunteer Opportunity Review of the CSP Community Page 6 Total to-date Application Deadline Nov. 13th

DIA CSP AHM 09-Nov-2016 Slide from May 2016

DIA CSP AHM 09-Nov-2016 Next Topic & Training Opportunities What do you want to hear about? Collaborate about? Learn? Working Groups? Training Opportunities

Slide from May 2016 DIA CSP AHM 09-Nov-2016 Survey Results from May 2016 Question 8 - What topics are you interested in? How did they Rank? CURRENT TRENDS # 2 Going back to basics INDUSTRY GUIDANCE/REGULATIONS # 1 HARMONIZATION OF PROCESS # 4 SAFETY DATA COLLECTION TOOLS/PROCESS # 3 DIS CSP Community Tools EU PV Module IV Generic & Other Drug Labeling/ Legislation Devices CSP Cross-functional collaboration Education & Certification REGULATORY REPORTING REQUIREMENTS # 4 Slide from May 2016

Who wants to volunteer for First topic 2017? DIA CSP AHM 09-Nov-2016 Survey Results from May 2016 Question 8 - What topics are you interested in? How did they Rank? CURRENT TRENDS # 2 Going back to basics INDUSTRY GUIDANCE/REGULATIONS # 1 HARMONIZATION OF PROCESS # 4 SAFETY DATA COLLECTION TOOLS/PROCESS # 3 DIS CSP Community Tools EU PV Module IV Generic & Other Drug Labeling/ Legislation Devices CSP Cross-functional collaboration Education & Certification REGULATORY REPORTING REQUIREMENTS # 4 Who wants to volunteer for First topic 2017?

DIA CSP AHM 09-Nov-2016 Training Opportunities Survey results indicated the community was unaware of DIA Training and e-learning courses available to CSP community Beth & Catherine are working with the learning group to schedule a call where we can review what is available for yourself and/or your colleagues for ongoing training within Safety Potentially next topic for December 2016 meeting… hopefully  Do any of the community team members want to volunteer to present a training session or webinar on a safety topic?

DIA CSP AHM 09-Nov-2016 Open Forum