Pharmacovigilance teams
Operational and strategic learning for global, regional and local pharmacovigilance functions.
Training & speaking
Pharmacovigilance learning that supports sound decisions
Reinhold delivers tailored training, executive briefings and speaking formats for pharmaceutical professionals, decision-makers and academic audiences. His sessions connect regulatory expectations with operational reality, helping participants understand responsibilities, recognise risks and make well-reasoned decisions.
At a glance
- Tailored to the audience
- English or German
- Online or on-site
- International delivery
Regulatory knowledge becomes valuable when people can apply it under real operational conditions.
Audiences
Designed around responsibility, not job titles
The depth, examples and level of discussion are adapted to the responsibilities, experience and operating context of each audience.
Decision-makers and leaders
Focused briefings on governance, accountability, risk and defensible decision-making.
Cross-functional partners
Shared understanding for colleagues working across Pharmacovigilance, Quality, Regulatory Affairs, Medical Affairs and related functions.
Academic and early-career audiences
Clear connections between regulatory foundations, professional responsibility and real operational practice.
Approach
From regulatory requirements to operational judgement
Effective pharmacovigilance learning should do more than repeat requirements. Participants need to understand why a responsibility exists, where risks arise, how decisions are documented and when an issue requires escalation.
Each format is adapted to the audience, organisational context and learning objectives. Examples, exercises and discussions are selected to support practical application without oversimplifying regulatory accountability.
- 01
Understand
Clarify responsibilities, expectations and regulatory context.
- 02
Apply
Connect requirements with realistic operational situations.
- 03
Decide
Strengthen judgement, escalation and documented accountability.
Training formats
Learning formats shaped around the audience
In-house training
Tailored learning for teams, functions or cross-functional groups.
Executive briefings
Focused sessions for leaders and decision-makers on governance, accountability and emerging risks.
Interactive workshops
Case-based formats that turn requirements into decisions, actions and documented reasoning.
Open seminars
Structured professional learning for participants from different organisations.
Online sessions
Focused live formats designed for remote and international audiences.
Academic teaching
Teaching that connects regulatory foundations with operational practice.
Speaking formats
Speaking formats for professional and academic audiences
Keynotes
Focused perspectives on pharmacovigilance, leadership, governance and responsible use of artificial intelligence.
Conference presentations
Evidence-based contributions tailored to the theme and audience of the event.
Panel discussions
Clear, balanced participation in discussions on regulatory, operational and leadership questions.
Professional dialogue and sparring
Structured exchange for leaders, specialists or small groups addressing complex questions.
Topic architecture
Core topic areas
Topics can be combined into introductory, advanced or leadership-focused formats. The final scope is agreed according to the audience and intended learning outcomes.
PV foundations and governance
Build a shared understanding of the systems, roles and evidence that support accountable oversight.
Show topics
- Pharmacovigilance foundations
- Global pharmacovigilance systems
- EU QPPV responsibilities and PV governance
- Pharmacovigilance System Master File
Scientific and regulatory responsibilities
Connect regulatory expectations with the scientific reasoning behind safety decisions.
Show topics
- GVP and regulatory requirements
- Signal management
- Risk management
- Benefit-risk evaluation
Operations, quality and oversight
Examine how robust operations, interfaces and evidence sustain inspection-ready systems.
Show topics
- Inspection and audit readiness
- Literature monitoring
- Safety data and case management
- Interfaces with Quality and Regulatory Affairs
Leadership and emerging practice
Explore accountable leadership and technology use where judgement remains essential.
Show topics
- Artificial intelligence in pharmacovigilance
- Leadership in regulated organisations
- Governance under operational pressure
- Decision-making and accountability
Programme examples
Examples of tailored programmes
The following examples illustrate how topics can be combined. Scope, duration and emphasis are agreed individually.
Global PV governance
For global, regional or affiliate teams addressing oversight, roles, interfaces and evidence of effective governance.
Discuss this formatShow details
- Audience
- Global, regional and affiliate teams
- Possible focus
- Oversight, roles, interfaces and governance evidence
- Delivery
- Online or on-site
QPPV and senior accountability
For decision-makers exploring QPPV responsibilities, oversight expectations, escalation and organisational positioning.
Discuss this formatShow details
- Audience
- QPPVs, leaders and decision-makers
- Possible focus
- Oversight, escalation and organisational positioning
- Delivery
- Briefing, workshop or seminar
Inspection readiness
For teams preparing systems, evidence, responsibilities and decision processes for audits or regulatory inspections.
Discuss this formatShow details
- Audience
- PV teams and cross-functional partners
- Possible focus
- Systems, evidence, responsibilities and decisions
- Delivery
- Online or on-site
Responsible AI in pharmacovigilance
For organisations examining governance, validation, human oversight, risk assessment and accountability in the use of artificial intelligence.
Discuss this formatShow details
- Audience
- Leaders, specialists and cross-functional teams
- Possible focus
- Governance, validation, oversight and risk
- Delivery
- Briefing, workshop or keynote
Track record
Selected engagements
A selection of recent training courses, conference contributions and invited talks.
- 2026 — FORUM Institut für Management · The EU Qualified Person for Pharmacovigilance (EU QPPV) · two-day seminar, English, with Dr Tanja Peters
- 2026 — Online Pharma FORUM · Human-in-the-loop AI in pharmacovigilance · invited talk
- 2026 — European Drug Safety & AI, Barcelona · conference speaker
- 2025 — FORUM Institut für Management · SOPs in der Pharmakovigilanz · one-day seminar, sole speaker
- 2025 — FORUM Institut für Management · Expert-FORUM: Drug Safety in der digitalen Welt · webcast series, including an AI case study on ICSR processing
- 2025 — Chem Academy · AI applications in pharmacovigilance: legal framework and recommendations · conference presentation
- 2024 — Chem Academy · Information management in pharmacovigilance and workshop on data science and AI · conference contribution
Recurring seminar formats are listed once. Further references are available on request.
Conferences
Conference Contributions
Selected conference contributions on pharmacovigilance, artificial intelligence, case management, and the practical implementation of human-in-the-loop AI solutions.
2026
17th International SLS Days
GxP / AI Governance: From interesting tools to controlled processes
- Date
- 18 September 2026
- Location
- Hannover, Germany
- Organizer
- SLS
- Type
- Conference Presentation
5th Pharmacovigilance & Drug Safety Conference
Human-in-the-Loop AI for Pharmacovigilance Case Intake: From Raw Emails to Validated E2B(R3) with Measurable QC Time Savings
- Date
- 29 April 2026
- Location
- Madrid, Spain
- Organizer
- UBIQ Events
- Type
- Conference Presentation
European Drug Safety & AI 2026
Human-in-the-Loop AI for Pharmacovigilance Case Intake: From Raw Emails to Validated E2B(R3) with Measurable QC Time Savings
- Date
- 24 February 2026
- Location
- Barcelona, Spain
- Organizer
- Why Summits
- Type
- Conference Presentation
2025
World Drug Safety Congress Americas
AI in Case Management: Limits and Opportunities
- Date
- November 2025
- Location
- Boston, Massachusetts, USA
- Type
- Conference Presentation
World Drug Safety Congress Europe
AI in Case Management: Limits and Opportunities
- Date
- 7–8 October 2025
- Location
- Amsterdam, Netherlands
- Type
- Conference Presentation
Chem-Academy Conference
How a Small Company Revolutionized Its Case Intake with theralyze.ai: AI-Powered E2B(R3) Generation for Safety Databases with Human QC, Saving Time and Reducing Manual Effort
- Date
- 2025
- Type
- Conference Presentation
Delivery
Delivery and language
- Languages
- English and German
- Delivery
- Online and on-site
- Location
- International delivery
- Design
- Content, examples and format agreed individually
Process
A clear path from enquiry to delivery
- 01
Context
Clarify the audience, operating environment and purpose.
- 02
Objectives
Define what participants should understand or be able to apply.
- 03
Design
Agree topics, examples, interaction and delivery format.
- 04
Delivery
Deliver the session and provide agreed supporting materials.
Related work
Connected expertise and teaching
Explore the underlying expertise
Training and speaking formats draw on Reinhold’s operational experience across pharmacovigilance governance, scientific assessment, quality systems, regulatory compliance and leadership.
Academic Teaching
Explore Reinhold’s work with academic institutions and postgraduate professional education.
Practical Pharmacovigilance
A practitioner’s guide to EU pharmacovigilance, from case intake to benefit–risk judgement, with a trainee path and an executive path.
Enquiries
Discuss a training or speaking format
To explore a possible format, please share the intended audience, organisational setting, preferred language and the objectives you would like the session to address.
- Audience
- Topic or challenge
- Preferred format
- Language
- Location or online delivery