Training course · Prompt Engineering · Pharma & Life Sciences

Prompt Engineering for Pharma and Life Sciences

Vendor-neutral prompt engineering: roles, context, few-shot examples, prompt chains, prompt libraries and systematic quality checks.

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

“Prompt Engineering 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 Prompt Engineering productively, safely and transparently in Pharma & Life Sciences – from the fundamentals to advanced workflows.

Whether you use ChatGPT, Claude, Copilot, Gemini or Le Chat, the quality of the output depends largely on how the task is framed. Prompt engineering is the skill of conveying goal, context, constraints and desired format to a language model so that it reliably produces usable results. In this vendor-neutral practical day you learn proven techniques that work across all mainstream AI assistants: defining roles and audiences, selecting relevant context, working with examples and breaking complex tasks down into traceable steps. You try out every technique directly on tasks from your own working day.

The second part focuses on repeatability and quality across the team. You develop prompt templates with placeholders, build multi-step prompt chains for analysis, writing and review processes, and set up a shared prompt library. You learn to evaluate output systematically – with review criteria, test cases and targeted self-checks by the model – and to avoid typical pitfalls such as hallucinations, ambiguity and missing context. By the end you have a structured approach that works regardless of the tool you use and continues to pay off as new models arrive.

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 understand how language models process prompts and derive effective wording from this.
  • You structure prompts with role, context, task, constraints and output format.
  • You use few-shot examples and prompt chains for complex, multi-step tasks.
  • You create reusable templates and build a shared prompt library.
  • 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 language models process prompts
  • Core principles of language models: probabilities, context window, limitations
  • Why wording, order and examples change the result
  • What causes hallucinations and how prompts reduce them
  • Differences and common ground between mainstream AI assistants
Module 2 Building blocks of an effective prompt
  • Defining role, audience, task, context and output format
  • Stating constraints, exclusions and quality criteria
  • Structured input with sections, delimiters and tags
  • Asking the model to raise questions instead of making assumptions
Module 3 Advanced techniques
  • Zero-shot, one-shot and few-shot: setting style and structure with examples
  • Requesting step-by-step reasoning for complex tasks
  • Prompt chains: separating research, drafting, review and revision
  • Using change of perspective, counter-arguments and model self-critique
Module 4 Templates and prompt libraries
  • Creating reusable templates with placeholders and variables
  • Storing persistent instructions in projects, custom assistants and agents
  • Building, naming, maintaining and sharing a team prompt library
  • Documenting templates: purpose, inputs, expected output, owner
Module 5 Quality assurance and responsible use
  • Defining review criteria and scoring rubrics for AI output
  • Setting up test cases and systematically comparing and improving prompts
  • Verifying facts, figures and sources; establishing the four-eyes principle
  • Data protection, confidential content and transparency under GDPR and the EU AI Act
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

Some initial experience with at least one AI assistant such as ChatGPT, Claude, Copilot or Gemini is helpful; no technical background is required. 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 and access to at least one AI assistant, ideally the tool approved within your organisation.

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
  • Fri, 11 December 2026 Salzburg Request
  • Tue, 15 December 2026 Online Request
  • Wed, 20 January 2027 Bremen Request
  • Fri, 29 January 2027 Online Request
  • Tue, 9 February 2027 Augsburg Request

Frequently asked questions

Do these techniques work with every AI assistant?

Yes, the course is deliberately vendor-neutral. The principles – a clear task, relevant context, examples, structured output and review steps – work equally well in ChatGPT, Claude, Copilot, Gemini, Le Chat and other tools. Where assistants differ in detail, for example with projects or custom assistants, we show the corresponding features in each.

Won't better models soon make prompt engineering obsolete?

Models are getting better at interpreting vague requests, but they still cannot know what you do not tell them: audience, quality standards, internal requirements or relevant background. Good prompts are therefore mainly good task descriptions. Templates, prompt chains and quality checks also keep their value for teams as new models arrive.

What is a prompt library and how do we maintain it as a team?

A prompt library is an organised collection of proven templates for recurring tasks, each with its purpose, required inputs, a sample result and an owner. It can live in a shared document, a wiki or directly in the AI tool's projects. In the course you set up a first library and agree simple rules for maintenance and approval.

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 “Prompt Engineering 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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