Training course · ChatGPT · Pharma & Life Sciences

ChatGPT for Pharma and Life Sciences

Use ChatGPT safely and productively at work: projects, custom GPTs, data analysis, Canvas and privacy settings in team workspaces.

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

“ChatGPT 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 ChatGPT in the abstract, you work on tasks from your daily routine – with examples, exercises and templates from Pharma & Life Sciences.

For many business teams, ChatGPT is the first AI tool they use every day – yet there is a methodical gap between asking the odd question and achieving real productivity gains. In this hands-on day you learn to apply ChatGPT deliberately to recurring work: drafting and editing text, summarising documents, analysing spreadsheets and structuring decision papers. You work with Projects that keep files and instructions together, with Canvas for reworking longer documents, and with data analysis for Excel and CSV files. Every exercise is based on genuine tasks from your own function.

The second focus is scale and responsibility. You build a custom GPT that knows your templates, tone of voice and review rules, and that colleagues across the workspace can use. We also clarify which data belongs in ChatGPT and which does not, how Team and Enterprise workspaces differ from personal accounts, and which settings matter for model training, memory and sharing. You leave with a personal prompt library, a working GPT and clear ground rules for using ChatGPT responsibly across your organisation.

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 structured prompts that reliably produce usable results for your day-to-day tasks.
  • You organise your work in Projects and revise longer documents efficiently with Canvas.
  • You analyse spreadsheets and files with data analysis and critically verify the results.
  • You build a custom GPT for a recurring task and share it with your team.
  • 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 Foundations and effective prompting
  • How language models work: strengths, limitations and hallucinations
  • Building effective prompts with role, context, task and output format
  • Refining iteratively instead of starting over: follow-ups and correction loops
  • Choosing models and using web search and deep research appropriately
Module 2 Projects, Canvas and document work
  • Setting up Projects to group files, instructions and chats by topic
  • Summarising, comparing and interrogating long documents
  • Using Canvas to revise text and drafts section by section
  • Templates for emails, reports, minutes and presentation outlines
Module 3 Data analysis with spreadsheets and files
  • Uploading, cleaning and analysing Excel and CSV files
  • Calculating KPIs, replicating pivot logic and explaining variances
  • Generating charts and preparing them for presentations
  • Verifying results: checking calculation steps and sanity checks
Module 4 Custom GPTs for recurring tasks
  • Identifying and scoping good use cases for GPTs
  • Configuring instructions, knowledge files and conversation starters
  • Testing, improving and sharing a GPT within the workspace
  • Maintenance, change tracking for instructions and ownership in the team
Module 5 Privacy, workspaces and governance
  • Personal accounts versus Team and Enterprise workspaces
  • Settings for model training, memory, temporary chats and sharing
  • Handling personal and confidential data in line with GDPR
  • Internal usage policy and quality assurance for AI output
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; no prior AI knowledge is required. Feel free to bring your own non-confidential sample tasks from your daily work. 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 a ChatGPT account; a paid plan or access to your organisation's Team or Enterprise workspace is recommended for custom GPTs, Projects and data analysis.

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 Hanover Request
  • Thu, 17 December 2026 Online Request
  • Fri, 15 January 2027 Online Request
  • Mon, 25 January 2027 Munich Request
  • Thu, 4 February 2027 Online Request

Frequently asked questions

Do I need a paid ChatGPT licence for the course?

You can follow the fundamentals with a free account. However, features such as custom GPTs, Projects with larger files and advanced data analysis are tied to paid plans or come with far more generous limits there. Ideally you join with access to your organisation's Team or Enterprise workspace, so you practise under real conditions.

May I enter confidential company data into ChatGPT?

That depends on your plan, your contractual terms and your internal policy. In Team and Enterprise workspaces, content is not used for training by default, but GDPR and confidentiality obligations still apply. In the course you learn how to classify and anonymise data and how to choose the right settings.

How is a custom GPT different from a saved prompt?

A GPT bundles persistent instructions, knowledge files and optional tools such as web search or data analysis into a dedicated assistant. Colleagues can use it without any prompting skills and get consistent results. A saved prompt, by contrast, has to be copied and supplemented with context every time, which is far more error-prone.

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 “ChatGPT 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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