Training course · Claude · Pharma & Life Sciences

Claude for Pharma and Life Sciences

Claude as an AI assistant for knowledge work: projects, Artifacts, long documents, analysis and precise writing for teams.

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

“Claude for Pharma and Life Sciences” is designed for roles such as Regulatory affairs professionals, Quality assurance and Qualified Persons and Clinical operations and medical writers and shows step by step how to use Claude productively, safely and transparently in Pharma & Life Sciences – from the fundamentals to advanced workflows.

Anthropic's Claude has become a go-to AI assistant for demanding knowledge work: it handles very long documents, reasons transparently and writes in a measured, easily steerable style. In this practical day you learn to exploit these strengths systematically. You analyse lengthy reports, contracts or policies, compare several sources and extract key findings with references to the exact passages. With Projects you store background knowledge and working instructions permanently, so Claude knows your terminology, templates and quality standards and you no longer start from scratch with every request.

We also show how to use Artifacts to produce standalone deliverables – structured documents, tables, charts or small interactive tools – and share them with your team. You analyse files with the built-in analysis capability, use research and connectors to company data, and put Claude to work as a critical reviewer of your own writing. A dedicated session covers Team and Enterprise plans, access management and data protection. By the end you have tested project set-ups and prompt patterns that you can apply straight away in your own function.

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 write precise, structured instructions that let Claude handle complex tasks reliably.
  • You analyse long and multiple documents and obtain referenced, verifiable summaries.
  • You set up Projects with a knowledge base and style rules and share them with your team.
  • You use Artifacts and the analysis capability to produce usable documents, tables and evaluations.
  • 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 Understanding and directing Claude
  • Model family, strengths and limitations compared with other assistants
  • Clear instructions with context, examples and the desired output format
  • Structured input using sections and tags for complex tasks
  • Extended thinking and step-by-step approaches for demanding questions
Module 2 Analysing long documents
  • Uploading and querying large PDFs, reports and contract sets
  • Comparing multiple documents and surfacing contradictions
  • Summaries with references to specific passages
  • Deriving checklists and review grids from policies and guidelines
Module 3 Projects and knowledge base
  • Creating Projects with knowledge documents and persistent instructions
  • Storing style and terminology rules for consistent results
  • Sharing Projects with the team and developing them together
  • Making good use of connectors to drives and business applications
Module 4 Artifacts, analysis and writing
  • Creating Artifacts for documents, tables, charts and interactive tools
  • Analysing files and spreadsheets with the built-in analysis capability
  • Drafting, shortening, rewording and tailoring text to audiences
  • Using Claude as a critical reviewer of arguments and gaps
Module 5 Team use, data protection and quality
  • Team and Enterprise plans: administration, roles and sharing
  • Handling confidential and personal data in line with GDPR
  • Checking output: verifying facts, figures and quotations
  • Defining internal guidelines and reusable prompt patterns
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

Confident use of office applications and a web browser; prior AI experience is helpful but not required. Your own non-confidential documents are welcome as practice material. You work in the pharmaceutical, biotech or medtech industry and know the GxP basics of your area.

Technical requirements

A laptop with an up-to-date browser or the Claude desktop app and a Claude account; we recommend Pro, Team or Enterprise access for Projects and larger files.

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.

  • Tue, 24 November 2026 Online Request
  • Wed, 9 December 2026 Berlin Request
  • Mon, 14 December 2026 Online Request
  • Thu, 14 January 2027 Online Request
  • Wed, 27 January 2027 Stuttgart Request
  • Fri, 12 February 2027 Online Request

Frequently asked questions

How does Claude differ from ChatGPT in everyday work?

Both are capable general-purpose assistants. Claude particularly stands out with very long documents, careful reasoning and an easily steerable writing style, while Projects and Artifacts support structured work. Which tool fits better depends on your tasks, integrations and company policies – the course gives you criteria for an informed assessment.

What are Artifacts and why would I use them?

Artifacts are standalone deliverables that Claude creates in a separate panel next to the chat – a document, a table, a chart or a small interactive tool, for example. They can be revised in a targeted way, downloaded and shared. A conversation therefore produces ready-to-use results rather than scattered fragments of text.

Is my data used to train Claude?

On Team and Enterprise plans, business content is not used for model training as a matter of principle. For individual accounts this depends on settings you should review yourself. Regardless of the plan, GDPR and internal confidentiality rules apply. In the course we walk through the relevant settings and the questions to ask.

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 “Claude 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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