Safety Data Exchange Agreements (Brief) An integral part of enterprise risk management systems Strategic management framework Governance model Standards, mechanisms, and metrics for management oversight Roles and responsibilities Stakeholder collaboration Procedural documents and SDEA templates CAPA management processes Supporting systems Document repositories

1. SDEAs
Integral part of enterprise risk management
11/10/2016©Arete-Zoe, LLC

2. 11/10/2016©Arete-Zoe, LLC
Compliance management
Article 11(1) of the Commission Implementing Regulation (EU) No 520/2012
Specific quality system procedures and processes shall be in place in order to ensure:
(a) Continuous monitoring of PV data, options for risk minimization and prevention and appropriate measures by MAH
(b) Scientific evaluation of all information on the risks of medicinal products by MAH
(c) Submission of accurate and verifiable data on serious and non-serious adverse reactions to the EudraVigilance
(d) Quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid
duplicate submissions and to validate signals
(e) Effective communication by the MAH with the national competent authorities and the Agency:
- Communication on new risks or changed risks
- Pharmacovigilance system master file
- Risk management systems, risk minimization measures
- PSURs, CAPAs, and PASS
(f) Update of product information in the light of scientific knowledge, EMA portal assessments and recommendations
(g) Appropriate of relevant safety information to healthcare professionals and patients.

3. 11/10/2016©Arete-Zoe, LLC
Safety Data Exchange -USA
The FD&C Act and applicable regulations cover post-marketing adverse event reporting for
• Rx and non-Rx drugs with approved NDAs (21 CFR 314.80 and 314.81)
• Prescription drugs and nonprescription drugs that have approved abbreviated new drug
applications (21 CFR 314.98 and 314.81)
• “Subpart H” drugs approved under accelerated approval (21 CFR 314.540)
• “Subpart I” drugs approved when human efficacy studies are not possible (21 CFR 314.630)
• Non-application nonprescription drug products (FD&C Act Chapter VII, Subchapter H,
Section 760) (Over-the Counter (OTC) Monograph)
• Licensed therapeutic biological products (21 CFR 600.80, 601.28, and 601.70)
• Biological products approved under accelerated approval (21 CFR 601.44)
• Biological products approved when human efficacy studies are not possible (21 CFR 601.93)
Marketed prescription drugs not the subject of approved applications (21 CFR 310.305)1

4. 11/10/2016©Arete-Zoe, LLC
Safety Data Exchange - EU
Europe
Regulation (EC) No 726/2004 with respect to centrally authorized medicinal
products
Directive 2001/83/EC with respect to nationally authorised medicinal products
(including MRP and DCP)
Commission Implementing Regulation (EU) No 520/2012 includes details on
certain aspects of pharmacovigilance
Good pharmacovigilance practice guidelines (GVP)

5. Strategic management framework
11/10/2016©Arete-Zoe, LLC
Complexity scales up with size of the enterprise
External
Material
Labor
Information
Material
Labor
Information
Internal
Production
Facilities
Relations
Jurisdictional
boundaries

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Governance model
Change
Acquisition
Strategic partnership
Legacy product
New vendor Outsourcing
Reorganization

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Roles and responsibilities
Change
Acquisition
Strategic partnership
Legacy product
New vendor Outsourcing
Reorganization
Functional
charts and
diagrams

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Roles and responsibilities
Functional
charts and
diagrams by
jurisdiction
Version control
Change control
Legislation
Industry regulations
Guidelines, non-binding recommendations, policies

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Supply & Distribution Channels
PV, QA/RA
HQ
Manufacturing
Distributors
High-volume products with
predictable demand
Cold-chain
Specialty pharmacies, niche
SDEAs ensure
multidirectional exchange
of information across
multiple jurisdictions
Packaging

10. MORT Analysis
Management Oversight & Risk Tree
11/10/2016©Arete-Zoe, LLC
• .
A safety system/program is a formal approach to eliminate/control hazardous
events through engineering, design, education, management policy, and
supervisory control of conditions (environment) and practices.
DESIGN TRAINING
MANAGEMENT SUPERVISION
CONTROLS

11. Procedural documents
SDEA templates
• Change control
• Version control
• Document management system
• Process review
11/10/2016©Arete-Zoe, LLC
Co-marketing
Distribution
Co-Promotion
Vendors
Service
providers
Others

12. CAPA management
processes
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Data
Collection
Assessment CAPA Inform Follow-up
Root cause methods
- Events and causal factor analysis
- Change analysis
- Barrier analysis
- Management Oversight and Risk Tree (MORT)
- Human performance evaluation
- Kepner-Tregoe model

13. Supporting systems
11/10/2016©Arete-Zoe, LLC
Data Breach Scenarios
• The Human Element:
• Insider threat
• Victim of exploitation
• Conduit devices misuse and tampering
• Exploitation of interface settings
• Misconfiguration by user
• Reconfiguration by intruder
• Sophisticated/special purpose illicit software

14. Document repositories
11/10/2016©Arete-Zoe, LLC
Source documents
Other relevant information
SDEAs
Confidentiality agreements
Contracts
CIOMS forms
SOPs
Organizational hierarchies
Evaluation and validation
documents
CAPA plans
RMPs

15. Strategic management framework
Penalty for
non-
compliance
Loss of IP
Litigation
Liability
Denial of
market
access
Consumer
rejection
11/10/2016©Arete-Zoe, LLC
Internal and
external inter-
dependencies
Sole-source
supply chain
Overspecialization
Lean
operations
Personnel
turbulence
Compliance
failure
Incompetence
Corruption
Accident
Civil disruption
Crime
Organized
crime
Business sector
competitors
Severe weather
Natural disaster