Webcast: Navigating AI in Regulatory Affairs
From A to Z - Legal framework, data management, submission, inspection readiness & more
- 5 concise webcast modules
- Legal, operational and strategic perspectives
- Use cases and practical applications
- Officially certified according to ISO 9001 and 21001
Series (completed)
From
1.790,00 €
plus VAT
Services & Process
Veranstaltung - 1.790,-€ zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
Period:
each from 10:00 a.m. - 12:00 a.m. CET:
02.03.2027
04.03.2027
09.03.2027
11.03.2027
16.03.2027
Booking details
Series (completed)
From
1.790,00 €
plus VAT
Services & Process
Veranstaltung - 1.790,-€ zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
Period:
each from 10:00 a.m. - 12:00 a.m. CET:
02.03.2027
04.03.2027
09.03.2027
11.03.2027
16.03.2027
This webcast series examines the use of artificial intelligence in regulatory affairs from legal, operational and strategic perspectives.
Your speakers
Dr. Manfred Eis
Opella (Sanofi Carve-Out)
Digital Lead - Regulatory, Pharmacovigilance & Medical IT
Your speaker
Dr. Manfred Eis
Opella (Sanofi Carve-Out)
Digital Lead - Regulatory, Pharmacovigilance & Medical IT
Fiona Maini
Life Sciences and Healthcare Digital Transformation Leader
Fiona has more than 25 years' experience at the intersection of life sciences, regulation and technology. She is now an independent consultant…
Your speaker
Fiona Maini
Life Sciences and Healthcare Digital Transformation Leader
Fiona has more than 25 years' experience at the intersection of life sciences, regulation and technology. She is now an independent consultant advising on adopting AI in regulated environments, with a focus on AI strategy, governance, and implementation.
In 2026, Fiona took time out to study 'Leadership in Artificial Intelligence' at Cambridge Judge Business School.
Prior to this, Fiona was Senior Director, Global Compliance and Strategy at Medidata (a Dassault Systèmes company), where she led engagement with regulators and industry bodies on emerging clinical trial technologies. She chaired the ACRO Decentralised Clinical Trials Working Group and the EUCROF New Technologies Working Group. Fiona has been a member of the EU AI Alliance and contributed to the EMA Inspectors Working Group workshops on AI in clinical trials.
Previously at Deloitte, Fiona headed the Centre for Regulatory Excellence in Life Sciences, delivering programmes for pharmaceutical and medical device companies. She also oversaw Deloitte's services to the European Medicines Agency, including work on the strategy for the EMA's SPOR programme, the foundation of IDMP implementation in the EU.
She holds a BSc in Chemistry and Management Science and an MSc in Chemistry from the University of Kent.
Dr. Pascal Hofer
F. Hoffmann-La Roche AG, Basel
Keine ausführliche englische Beschreibung vorhanden
Your speaker
Dr. Pascal Hofer
F. Hoffmann-La Roche AG, Basel
Keine ausführliche englische Beschreibung vorhanden
Florian Woeste
PHAROS Labs GmbH, GERMANY
Florian Woeste currently serves as Managing Director at PHAROS Labs. With eight years of experience in machine learning and artificial intelligence, Florian Woeste has…
Your speaker
Florian Woeste
PHAROS Labs GmbH, GERMANY
Florian Woeste currently serves as Managing Director at PHAROS Labs. With eight years of experience in machine learning and artificial intelligence, Florian Woeste has extensive expertise in deploying AI and guiding projects to successful completion.
What to Expect
- The Legal and Compliance Framework
- AI-Powered Regulatory Writing & Submissions
- Structured Data & AI
- Agentic AI & Intelligent Automation in Regulatory Operations
- Inspection Readiness for AI in Regulated Environments
Who Should Attend
This webcast series is aimed at regulatory affairs professionals and managers involved in regulatory operations, submissions, structured data or AI transformation. It is also relevant for professionals responsible for compliance, inspection readiness, quality interfaces or change management in regulated environments.
Participants are expected to have a solid understanding of EU regulatory procedures.
Objective of the Event
This webcast series provides an end-to-end overview of artificial intelligence in regulatory affairs. Across 5 modules, participants examine the legal and compliance framework for AI, inspection readiness, AI-supported regulatory writing and submissions, the role of structured data and agentic AI.
Each module focuses on a specific area of AI in the regulatory landscape. Together, the modules provide a structured overview of the opportunities, requirements and challenges involved in applying AI in regulatory affairs. They also offer practical perspectives on how to assess AI use cases and support their implementation in regulated environments.
Your Benefit
- You gain a structured overview of the legal and compliance requirements for AI in regulatory affairs.
- You learn how authorities and inspectors may assess the use of AI in regulated environments.
- You understand how AI can support eCTD submission management, CTD authoring and quality assurance of regulatory content.
- You identify why structured content management is key for AI usage and what agentic AI means for regulatory operations.
Programm
from 10:00 a.m. to 12:00 a.m. CET
10:00 - 12:00
Dr. Pascal Hofer
- Regulatory frameworks for AI: EU AI Act, FDA draft guidance & global perspectives
- GMP Annex 11 and Annex 22: specific requirements and their application to AI tools
- Data protection, business secrets and IP
- AI risk management in practice: Contracts, QM interfaces and compliance governance
10:00 - 12:00
Fiona Maini
- IDMP, ISO standards and the shift towards structured data in regulatory affairs
- Structured content management (SCM) as the gold standard for the use of AI
- Where AI can accelerate the shift: data extraction, migration and mapping
10:00 - 12:00
Dr. Manfred Eis
- From chatbots to AI agents: what "agentic AI" means for reg ops
- Use cases from an industry perspective
- Validation and GxP compliance of AI agents
- Bridging the gap: applying Quality by Design principles to AI trustworthiness in regulated environments
10:00 - 12:00
Florian Woeste
- AI-assisted eCTD submission management
- GenAI for CTD authoring
- Quality assurance in AI-generated regulatory content
10:00 - 12:00
Fiona Maini
- Overview of the AI regulatory context and guiding principles
- AI is increasingly embedded in regulatory and quality activities, an overview of some practical examples
- Insights from discussions with inspectors on how they are approaching the inspection of AI in validated systems
- Practical discussion on inspection readiness where AI is in use in a regulated environment
10:00 - 12:00
Module 1: AI in RA - the Legal and Compliance Framework (02.03.2027)
Module 1: AI in RA - the Legal and Compliance Framework (02.03.2027)
Dr. Pascal Hofer
- Regulatory frameworks for AI: EU AI Act, FDA draft guidance & global perspectives
- GMP Annex 11 and Annex 22: specific requirements and their application to AI tools
- Data protection, business secrets and IP
- AI risk management in practice: Contracts, QM interfaces and compliance governance
10:00 - 12:00
Module 2: Structured Data & AI (04.03.2027)
Module 2: Structured Data & AI (04.03.2027)
Fiona Maini
- IDMP, ISO standards and the shift towards structured data in regulatory affairs
- Structured content management (SCM) as the gold standard for the use of AI
- Where AI can accelerate the shift: data extraction, migration and mapping
10:00 - 12:00
Module 3: Agentic AI & Intelligent Automation in Regulatory Operations (09.03.2027)
Module 3: Agentic AI & Intelligent Automation in Regulatory Operations (09.03.2027)
Dr. Manfred Eis
- From chatbots to AI agents: what "agentic AI" means for reg ops
- Use cases from an industry perspective
- Validation and GxP compliance of AI agents
- Bridging the gap: applying Quality by Design principles to AI trustworthiness in regulated environments
10:00 - 12:00
Module 4: AI-Powered Regulatory Writing & Submissions (11.03.2027)
Module 4: AI-Powered Regulatory Writing & Submissions (11.03.2027)
Florian Woeste
- AI-assisted eCTD submission management
- GenAI for CTD authoring
- Quality assurance in AI-generated regulatory content
10:00 - 12:00
Module 5: Inspection Readiness for use of AI in Regulated Environments (16.03.2027)
Module 5: Inspection Readiness for use of AI in Regulated Environments (16.03.2027)
Fiona Maini
- Overview of the AI regulatory context and guiding principles
- AI is increasingly embedded in regulatory and quality activities, an overview of some practical examples
- Insights from discussions with inspectors on how they are approaching the inspection of AI in validated systems
- Practical discussion on inspection readiness where AI is in use in a regulated environment
Downloads
Request the documents using our form.
List of abbreviations "Drug Regulatory Affairs and CMC"
More information
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
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Further Information
Qualification Course Regulatory Affairs Manager
Expand your competencies in drug regulatory affairs in a practice-oriented manner with up to 30% price advantage.
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Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de