Effective Auditing of PV Interfaces

Transcription

1 Outline Effective Auditing of PV Interfaces SQA Meeting March 29, 2017 Larry Thomas, RQAP-GLP, CQA Bayer Pharmaceuticals Whippany, NJ Audit Process Planning/Preparation, Execution and Reporting Functions / Areas Sales, Marketing, Medical Information, etc. Programs / Studies Patient Support Programs Non-interventional Studies Digital Media, etc. 1

2 Audit Process Audit Process Audit Master Plan Scheduling / Audit Plan Preparation Execution Reporting 2

3 Functions & Areas Interfaces to Drug Safety Med Info Sales & Mkting Medical Affairs Drug Safety Clinical Product Quality Reg Affairs Medical Affairs Oversight and interfaces Product Advice (emergency cases and clinical trials) Medical Science Liaison (MSL) Promotional Materials MA managed programs IT Systems Other (Medical Devices Vigilance too) 3

4 Medical Information Inquiries Procedures References Complex inquiries via Medical Dept Adverse Events and Product Technical Complaints Various channels (phone, , internet, etc.) MHRA Inspection Findings There is a lack of documentation within the medical information enquiry files to demonstrate that appropriate questions have been asked to determine whether an enquiry relates to a specific patient with an adverse reaction. There are inadequate or no mechanisms in place to ensure that all adverse reactions have been appropriately identified and transferred to the PV department from other internal departments, for example medical information, or from external partners. 4

5 Sales MHRA Inspection Finding Marketing Off label inquiries AEs/PTCs Contacts (CRM systems) Promotional materials The MAH does not have an effective mechanism for controlling RSI, such as SPCs/PILs, and ensuring that employees have access to the most current version. Promotional materials (approval / management) Active On-line Listening (other areas too) Advisory Boards Market Research (materials, AEs/PTCs) 5

6 Miscellaneous FDA Observations by Category (2016) FDA/MHRA Inspection Findings GMP Quality Group IT Quality Management System 3% 2% 8% 4% 10% 11% 22% 40% Written Procedures Product Technical Complaints Safety Notification & Submission Quality Management Periodic Safety Reporting PV Case Processing Oganization, Roles, Responsibilites Others < 2% each Coverage of potential sources of AEs/PTCs: All sources: foreign/domestic, internet, literature, employees, etc. Complaints logged in Not all computer systems used for PV activities have had an assessment of their regulatory status and need for validation. Page 17 6

7 Programs and Studies What is a PSP? Involve direct interaction with patients/caregivers/hcps and purpose is not to generate safety/efficacy information Purpose is to support patient care, typically by supplementing care/guidance or arranging financial assistance Not formal studies driven by a protocol May not be product specific Not designed to be an organized data collection scheme 7

8 PSPs - Background PSPs Key Aspects Post Approval Safety Studies 2012 Roche MHRA/EMA inspection 80,000 cases with 15,000 deaths 2014 Novartis Japan Failure to report AEs 15-day shutdown Awareness of all programs Program descriptions / Materials Informed Consent (data privacy) Vendors / Contracts Computer systems Written procedures AEs and PTCs PASS Interventional Studies (clinical trials regulations) Non Interventional Studies (observational studies) Page 24 EMA Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies 8

9 Terminology Observational Studies Investigator Initiated Research Observational Study Intent is simply to observe No intervention between the patient and physician Drug prescribed according to label No additional monitoring/diagnostic procedures Includes patient registries Key Points: Primary vs Secondary Protocol Vendors Data management plan & Statistical Analysis Plan AEs/PTCs Report Key Points: Unsolicited Contract (milestones, fair market value) IMP handling Protocol (amendments) AEs/PTCs Data ownership and publication 9

10 Digital Media Websites, Social Media, etc. Apps as devices Medical Software 10

11 Conclusion Additional Readings AE recognition and handling Vendor oversight and contracts Studies: protocols, documentation, reporting, etc. Guideline on good pharmacovigilance practices (GVP) Module IV Pharmacovigilance audits EMA Guideline on good pharmacovigilance practices (GVP) Module VIII Postauthorisation safety studies Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions Thank You 11