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

2. 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

3. 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

4. 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

5. 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

6. 2017 PV & Risk Management Strategies Conference
DIA CSP AHM 09-Nov-2016
2017 PV & Risk Management Strategies Conference

7. 2017 PV & Risk Management Strategies Conference
DIA CSP AHM 09-Nov-2016
2017 PV & Risk Management Strategies Conference

8. 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?

9. 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

10. 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?

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

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

13. 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

14. 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

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

16. 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

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

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

19. 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

20. 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?

21. 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?

22. DIA CSP AHM 09-Nov-2016
Open Forum