Training course · Vibe Coding · Pharma & Life Sciences

Vibe Coding for Pharma and Life Sciences

Build software in natural language: from prompt to app, rapid iteration, quality and security checks, and turning prototypes into production.

Duration
2 days (14 hrs)
Format
Online or on-site
Language
German or English
Participants
open dates or exclusive for your team
Certificate
Certificate of attendance

Overview

“Vibe Coding for Pharma and Life Sciences” is a hands-on course for roles such as Regulatory affairs professionals, Quality assurance and Qualified Persons and Clinical operations and medical writers. Rather than learning Vibe Coding in the abstract, you work on tasks from your daily routine – with examples, exercises and templates from Pharma & Life Sciences.

Vibe coding lets business users without any programming knowledge build digital tools of their own. You describe in everyday language what a mini app, dashboard or form should do, and tools such as Lovable, Claude, ChatGPT Canvas or Replit generate a working solution. Helpers for your daily work can take shape quickly, without waiting for IT to free up capacity. This course shows you step by step how to make it work, which habits lead to good results, and what really matters along the way.

During the course you build applications drawn from your own work: a KPI overview, a data entry form, a small calculator or an automation for recurring chores. At the same time you learn to assess the risks realistically. Which data may go into such tools, who will run and maintain the solution, and when must IT be involved? With this knowledge you can create useful solutions that are accepted within the organisation and remain secure and sustainable in the long term.

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 build your own mini apps, dashboards and forms through vibe coding without programming skills.
  • You describe requirements clearly enough for AI tools to produce usable solutions.
  • You improve your applications step by step and check the results for accuracy.
  • You automate simple recurring tasks in your working environment.
  • 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

Day 1

Module 1 Understanding vibe coding as a business user
  • What vibe coding is and what you can achieve without programming skills
  • Tools at a glance: Lovable, Claude, ChatGPT Canvas, Replit and similar platforms
  • Spotting good candidates for your own tools at work
  • Realistic expectations: strengths, limits and common pitfalls
Module 2 Describing and building your own mini app
  • Capturing goal, users, inputs and desired outcome in plain words
  • Generating a first version and clicking through it together
  • Improving look, wording and flow with targeted feedback
  • Saving milestones and returning to an earlier version when things go wrong
Module 3 Dashboards, forms and calculators
  • Turning Excel or CSV data into an interactive dashboard
  • Building entry forms with required fields and plausibility checks
  • Creating calculators and decision aids for your team
  • Checking results for accuracy with test data and spot checks
Module 4 Automating routine work
  • Identifying recurring tasks that lend themselves to automation
  • Building simple automations for reports, notifications or file storage
  • Discussing connections to existing tools via approved interfaces
  • Documenting automations clearly and handing them over to colleagues

Day 2

Module 5 Risks and coordination with IT
  • Which data may and may not go into AI tools: data protection and confidentiality
  • Managing access rights, sharing settings and public links deliberately
  • Avoiding shadow IT: clarifying operation, maintenance and ownership
  • Preparing a handover to IT when a solution grows or becomes critical
Module 6 Hands-on project: your own solution for Pharma & Life Sciences
  • Literature extraction table – An app where abstracts are pasted in and study design, population, endpoints and results are turned into an exportable comparison table.
  • CAPA tracker – An internal dashboard for non-GxP preliminary overviews that visualises open CAPAs, due dates and effectiveness checks and sends reminders.
  • Regulatory news feed – A tool that collects authority publications, filters them by topic and produces a weekly annotated overview for the regulatory team.
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.

Possible hands-on projects

Literature extraction table

An app where abstracts are pasted in and study design, population, endpoints and results are turned into an exportable comparison table.

CAPA tracker

An internal dashboard for non-GxP preliminary overviews that visualises open CAPAs, due dates and effectiveness checks and sends reminders.

Regulatory news feed

A tool that collects authority publications, filters them by topic and produces a weekly annotated overview for the regulatory team.

Prerequisites

No programming knowledge is required; confident use of a browser, office applications and spreadsheets is enough. You work in the pharmaceutical, biotech or medtech industry and know the GxP basics of your area.

Technical requirements

Your own laptop with an up-to-date browser, Git and an AI coding tool of your choice, such as an AI editor or coding agent with an active account.

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.

  • Thu, 26 November 2026 – Fri, 27 November 2026 Online Request
  • Tue, 8 December 2026 – Wed, 9 December 2026 Berlin Request
  • Mon, 14 December 2026 – Tue, 15 December 2026 Online Request
  • Wed, 13 January 2027 – Thu, 14 January 2027 Stuttgart Request
  • Wed, 20 January 2027 – Thu, 21 January 2027 Online Request
  • Tue, 2 February 2027 – Wed, 3 February 2027 Hanover Request

Frequently asked questions

Is vibe coding only suitable for quick prototypes?

Vibe coding shines with prototypes, internal tools and experiments. With the right practices, namely clear specifications, tests, reviews and sound version control, results can also be turned into production-ready applications. The course teaches you to manage that transition deliberately and to recognise early on when rebuilding is the wiser option.

Which tools are used in the course?

The course is vendor-neutral. We work with the main tool categories: AI editors such as Cursor or Windsurf, coding agents such as Claude Code or Codex, and browser-based app builders. You are welcome to use your preferred tool, as the principles of specification, iteration, quality and security apply to all of them.

How should I deal with security risks in generated code?

Generated code often contains typical weaknesses such as hard-coded credentials, missing input validation or overly open interfaces. You learn to check specifically for these patterns, build security requirements into the specification from the start, use automated scanning and require a deliberate human sign-off before every deployment.

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 “Vibe Coding for Pharma and Life Sciences” cost?

The course costs a flat €949 plus VAT per participant – whether online or on-site. This includes 2 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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