Training course · Generative AI · Pharma & Life Sciences

Generative AI for Pharma and Life Sciences

Vendor-neutral, hands-on day: how language models work, where they go wrong and how to roll out AI successfully in your team.

Duration
1 day (7 hrs)
Format
Online or on-site
Language
German or English
Participants
open dates or exclusive for your team
Certificate
Certificate of attendance

Overview

This course connects Generative AI with the everyday processes of Pharma & Life Sciences. Participants work on realistic scenarios and leave with prompts, workflows and checklists they can use straight away.

Generative AI has reached most organisations, yet teams often lack a shared understanding of what language models can actually do and where their limits lie. In this vendor-neutral course you will learn how large language models generate text, why they hallucinate and how careful prompting, context and source checking lead to reliable results. Rather than relying on any provider's marketing claims, you will work with transparent criteria that help you compare tools and judge their fit for your own tasks.

The second focus is everyday implementation. You will identify concrete use cases in your area of work, weigh benefit, risk and effort, and draft a realistic roll-out plan for your team. This covers ground rules for handling confidential data, a practical prompt library and ways to build acceptance and make results measurable. Throughout the day you work with examples from your own field, so you leave with an actionable roadmap rather than a set of abstract ideas.

Pharmaceutical, biotech and medtech companies operate in one of the most heavily regulated environments of all. Documentation, validation and traceability shape daily work from research and clinical trials to manufacturing. Generative AI offers significant potential: AI assistants review scientific literature, help draft study protocols, regulatory documents and SOPs, summarise deviation reports, support pharmacovigilance case processing and prepare medical information for healthcare professionals. Automation supports change control, CAPA tracking and regulatory intelligence. At the same time, as soon as AI touches GxP-relevant processes, validation, data integrity according to ALCOA+ and clear accountability are mandatory. Adoption succeeds when companies clearly separate non-regulated support from GxP use and involve quality assurance early.

The course is delivered live – either online in a virtual classroom or on-site in our training rooms in Munich, Salzburg, Berlin, Augsburg, Hanover, Bremen, Stuttgart and Kaiserslautern. We can also run it exclusively for your team.

Who is this course for?

  • Regulatory affairs professionals
  • Quality assurance and Qualified Persons
  • Clinical operations and medical writers
  • Pharmacovigilance and drug safety teams
  • Medical affairs and R&D scientists

Typical challenges we address

  • Producing extensive regulatory and scientific documents to a high standard
  • Processing deviations, CAPAs and change controls on time
  • Systematically evaluating growing volumes of literature and regulation
  • Using AI tools in a GxP-compliant, validatable way

What you will be able to do

  • You can explain clearly how language models generate text and why hallucinations occur.
  • You can write prompts that consistently deliver useful, verifiable results.
  • You can compare AI tools against transparent criteria covering data protection, features and cost.
  • You can identify and prioritise concrete use cases for your area of work.
  • Use AI for literature review, medical writing and regulatory intelligence.
  • Distinguish non-regulated AI use from GxP-relevant applications and understand validation requirements.
  • Safeguard data integrity, confidentiality and patient data protection when using AI.

Course outline

Module 1 How large language models work
  • Tokens, context windows and probabilities: what happens when a model generates text
  • Training knowledge versus web search versus your own documents (RAG)
  • Text, images, audio and code: what multimodal models can do today
  • Realistically assessing typical strengths and weaknesses in office work
Module 2 Spotting hallucinations and getting reliable output
  • Why models produce plausible-sounding errors and when the risk increases
  • Prompting techniques: role, context, examples, output format and step-by-step instructions
  • Requesting sources, cross-checking facts and introducing a four-eyes principle
  • Scoping tasks so that AI assists rather than decides
Module 3 Choosing tools without vendor bias
  • Overview of chat assistants, AI built into office suites and specialist tools
  • Criteria: data processing, hosting location, admin features, integrations and pricing model
  • Enterprise licences, API access and locally hosted open-source models compared
  • Building a simple scoring matrix for your own tool selection
Module 4 Identifying use cases in your field
  • Systematically capturing recurring writing, research and analysis tasks
  • Rating benefit, risk and implementation effort for each use case
  • Distinguishing quick wins from strategic initiatives
  • Creating a prioritised use-case backlog for your team
Module 5 Rolling out generative AI in your team
  • Usage rules: which data may go into which tool and who signs off results
  • Building and maintaining a shared prompt library and templates
  • AI champions, training formats and peer exchanges to embed new habits
  • Measuring success: documenting time saved, quality and user satisfaction
Module 6 Practice lab: Pharma & Life Sciences
  • Literature review and evidence
  • Medical writing support
  • SOPs and training materials
  • Deviations and CAPA
  • Regulatory intelligence
  • Pharmacovigilance support
Module 7 Data protection, quality & transfer to daily work
  • When AI systems are used in GxP-relevant processes, computerised system validation under EU GMP Annex 11 or 21 CFR Part 11 and data integrity according to ALCOA+ must be ensured. Clinical trial and pharmacovigilance data contain health data under Article 9 GDPR and may only be processed in pseudonymised form in approved environments.
  • Ground rules for safe AI use in your team
  • Checking results: facts, sources, tests and the four-eyes principle
  • Personal action plan for the next 30 days
  • Open questions, outlook and resources for further learning

Practical scenarios from your field

Literature review and evidence

An AI assistant summarises scientific publications, extracts study design, endpoints and results into tables and supports systematic reviews, with experts checking every data point against the original source.

Medical writing support

AI creates outlines and first drafts of study protocols, clinical study reports, investigator brochures or modules of the regulatory dossier based on approved templates and source data.

SOPs and training materials

Process descriptions and regulations are turned into draft SOPs, training slides and comprehension questions, which are then reviewed and approved through the validated document management system.

Deviations and CAPA

AI summarises deviation reports, structures root cause analyses, finds similar past cases and suggests CAPAs, which quality assurance evaluates and decides on.

Regulatory intelligence

Automations collect new guidelines and publications from the EMA, national authorities or the FDA; AI summarises changes and maps them to affected products and processes for an impact assessment.

Pharmacovigilance support

AI helps pre-structure case reports from unstructured text, extract relevant information on product, event and patient and detect duplicates, while medical assessment remains with qualified staff.

Prerequisites

No technical background is required. It helps to bring along typical tasks from your day-to-day work that you would like to support with AI. You work in the pharmaceutical, biotech or medtech industry and know the GxP basics of your area.

Technical requirements

You will need a laptop with an up-to-date browser and internet access. A free account with a common AI assistant is sufficient; company licences are welcome.

Data protection & compliance

When AI systems are used in GxP-relevant processes, computerised system validation under EU GMP Annex 11 or 21 CFR Part 11 and data integrity according to ALCOA+ must be ensured. Clinical trial and pharmacovigilance data contain health data under Article 9 GDPR and may only be processed in pseudonymised form in approved environments.

Suggested dates

All dates are suggestions – your preferred date is always possible.

  • Mon, 23 November 2026 Online Request
  • Tue, 1 December 2026 Kaiserslautern Request
  • Mon, 7 December 2026 Online Request
  • Thu, 14 January 2027 Online Request
  • Wed, 20 January 2027 Salzburg Request
  • Thu, 28 January 2027 Online Request

Frequently asked questions

Is the course tied to a specific AI tool?

No. The training is deliberately vendor-neutral. You work with widely used chat assistants and learn principles that apply to all major language models. That way you can transfer your skills to whichever tool your organisation has approved and evaluate new offerings yourself using clear criteria instead of relying on marketing statements.

How is confidential company data handled during the course?

For the exercises you use anonymised or fictitious examples from your area of work. At the same time you learn which categories of data may be entered into which tools, what to look for regarding data processing agreements and use of inputs for training, and how to set out these rules clearly for your team.

Will we leave with something concrete to implement?

Yes. You leave with a prioritised use-case backlog, a scoring matrix for tool selection, tested prompt templates and a draft set of team usage rules. These materials are designed so you can take them straight into internal discussions with management, IT and your data protection officer.

Do AI tools need to be validated in pharma?

It depends on the use. For activities without GxP relevance, such as internal communication or literature overviews, general IT and data protection rules apply. If results feed into GxP-relevant decisions or records, a risk-based validation approach is required. We show you how to classify use cases.

How do we ensure data integrity?

AI output must be attributable, traceable and verifiable. That means documented inputs and prompts, clearly assigned reviewers, versioning and release through your validated systems. In the course we discuss how ALCOA+ principles apply to AI-supported work steps. Clear retention rules complete the picture.

How much does “Generative AI for Pharma and Life Sciences” cost?

The course costs a flat €949 plus VAT per participant – whether online or on-site. This includes 1 training day(s) with a live trainer, course materials, a lab environment and a certificate of attendance.

Can I suggest my own date?

Yes. Our suggested dates are just a guide. In the request form you can always describe your preferred date or period in free text – we check availability and confirm within one working day.

Is the course online or on-site?

Both are possible: live online in a virtual classroom or on-site in Munich, Salzburg, Berlin, Augsburg, Hanover, Bremen, Stuttgart or Kaiserslautern. We can also run the course exclusively for your team.

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