Transforming Regulatory Affairs with ChatGPT-5.pptx
Download as PPTX, PDF0 likes307 views
This presentation explains 50 practical ways GPT-5 can help pharmaceutical regulatory affairs teams work faster and more accurately. It’s organized into 10 key areas, each with 5 specific applications, such as: Regulatory Intelligence – Tracking and summarizing new guidelines worldwide. Dossier Preparation – Drafting and formatting CTD/eCTD submissions. Labeling – Checking and creating compliant product labels and leaflets. Clinical Trial Support – Preparing applications and registry postings. CMC & Quality – Writing stability reports and control strategies. Safety & Pharmacovigilance – Summarizing safety data and detecting trends. Communication with Authorities – Drafting responses and meeting materials. Post-Approval Management – Handling renewals, variations, and tracking deadlines. Training – Creating onboarding and SOP training materials. Process Automation – Extracting data, setting reminders, and building dashboards. The core message: GPT-5 can automate routine tasks, improve compliance, and give teams more time for strategic work — but AI outputs must still be reviewed by human experts.
Transforming Regulatory Affairs with ChatGPT-5.pptx
- 1. Transforming Regulatory Affairs with ChatGPT-5 50 Practical Applications Transforming regulatory workflows with advanced AI applications across document preparation, compliance, and communication Sharan Murugan
- 2. Presentation Overview About This Presentation 10 regulatory affairs categories covered 50 unique GPT-5 applications with real examples Practical implementation guidance for regulatory teams 1 Regulatory Intelligence & Updates 2 Dossier Preparation & eCTD Support 3 Labeling & Artwork 4 Clinical Trial Regulatory Support 5 CMC & Quality Documentation 6 Safety & Pharmacovigilance 7 Communication with Authorities 8 Post-Approval Lifecycle Management 9 Training & Knowledge Management 10 Process Automation & Efficiency Each category contains 5 practical GPT-5 applications Made with Genspark All these points are either already been applied in many companies or being tried in pilot, some are still theory and in exploration phase! Anything related with AI generated needs to be carefully reviewed and needs a Human Touch! Agenda: 10 Key Application Categories Sharan Murugan Disclaimer: The views and opinions expressed on this profile are my own and do not necessarily reflect the official policy or position of my employer or any organization I am affiliated with.
- 3. ChatGPT-5inRegulatoryAffairs Why GPT-5 matters here – Can process massive regulatory documents, summarize guidelines, and tailor content for different health authorities. Pharma’s interest – Ideal for data- heavy, compliance-critical work like regulatory affairs, clinical research, safety monitoring, and medical writing. ChatGPT-5 – OpenAI’s newest AI model GPT-5 (released 07 Aug 2025) with advanced reasoning, multimodal input (text, image, audio), and faster, more accurate responses. Other GenAI tools – Claude 3 (Anthropic), Gemini (Google), LLaMA 3 (Meta), Mistral, plus pharma-specific AIs like Med-PaLM. Why the buzz – Dramatically reduces errors, follows complex instructions better, and delivers near expert-level output. Industry trend Pharma giants are investing in GenAI to speed submissions, track global rules in real-time, and strengthen compliance. GPT-5 is accessible to all users at no cost, but if you need advanced features, upgrading to paid tiers like Plus or Pro is necessary
- 4. Regulatory Intelligence & Updates 1 Summarize new regulatory guidelines instantly GPT-5 can process and simplify complex EMA, USFDA, MHRA, and CDSCO guidance documents into plain language summaries. "Summarize EMA's latest guidance on pediatric trials in plain English" 2 Compare differences between regulations Quickly identify and highlight key changes between different versions of regulatory standards. "Highlight changes in ICH E6 R3 vs R2" 3 Monitor global regulation changes Leverage web search capabilities to stay updated with regulatory changes across different markets. "Pull recent EU GMP Annex 1 updates" 4 Create regulatory intelligence newsletters Automatically generate monthly newsletters summarizing key regulatory developments. "Generate August regulatory update newsletter focusing on biologics" 5 Map regulatory timelines for multiple countries Create comparative tables of submission deadlines and requirements across different markets. "Create table of IND/NDA/MAA submission deadlines for US, EU, and Japan"
- 5. Dossier Preparation & eCTD Support 6 Draft CTD Module 2 summaries from scientific reports GPT-5 can automatically generate Quality Overall Summaries (QOS) and other Module 2 documentation from raw scientific and CMC data. "Generate QOS from CMC stability and characterization data" 7 Check eCTD formatting rules for each region Verify regulatory compliance of eCTD formatting elements like bookmarks, hyperlinks, and file specifications for different markets. "Are these bookmarks eCTD compliant for EMA submission?" 8 Create country-specific Module 1 templates Generate region-specific administrative documents and cover letters formatted to local regulatory requirements. "Create pre-formatted cover letters for India, US, and EU submissions" 9 Auto-populate repetitive CTD data from master file Transfer consistent information across multiple CTD sections to maintain accuracy and reduce manual entry errors. "Transfer product specifications to all relevant sections of the dossier" 1 0 Suggest optimal granularity for eCTD documents Provide guidance on appropriate document splitting and organization to optimize eCTD structure and reviewability. "Advise on optimal Module 3 structure for a complex biologic product" Sharan Murugan
- 6. Labeling & Artwork 1 1 Compare drug labels across markets GPT-5 can identify and highlight discrepancies between product labels in different markets to ensure consistency. "Compare US and EU labels for Product X and highlight all text differences" 1 2 Draft SmPC/PI from clinical & safety data Generate initial drafts of Summary of Product Characteristics or Package Inserts from clinical trial results. "Generate first draft SmPC section 4.8 based on provided clinical safety data" 1 3 Check labels for mandatory statements Automatically verify that all required regulatory warnings and statements are present on product labeling. "Check if this label contains all required EU pediatric warnings" 1 4 Create plain language patient leaflets Convert technical medical terminology into patient-friendly language for package leaflets. "Convert this technical adverse reaction section into simple language for patients" 1 5 Create QRD-compliant label templates Generate label templates that comply with the EMA's Quality Review of Documents formatting requirements. "Create a QRD-compliant template for a generic antibiotic product"
- 7. Clinical Trial Regulatory Support 1 6 Draft Clinical Trial Applications (CTA) forms GPT-5 can automatically generate and populate regulatory application forms for clinical trials across different jurisdictions. "Auto-fill EMA or CDSCO templates for phase II oncology trial" 1 7 Summarize trial protocols for ethics submissions Create concise, lay-friendly summaries of complex clinical trial protocols for ethics committee review. "Generate 2-page lay summary of diabetes trial protocol for IRB submission" 1 8 Flag missing regulatory documents Identify gaps in submission packages to prevent rejection during regulatory review processes. "Check submission package for missing documents like Investigator Brochure" 1 9 Map country-specific trial import license rules Create comprehensive guides for navigating different import requirements for clinical trial materials. "Generate import license requirements list for APAC region clinical trials" 20 Generate trial registry postings Create properly formatted entries for clinical trial registries in compliance with global standards. "Format trial data for ClinicalTrials.gov and WHO registry submission" Sharan Murugan
- 8. CMC & Quality Documentation 2 1 Draft stability summary reports from raw data GPT-5 can analyze stability testing data and automatically generate well-structured summaries for regulatory submissions. "Generate Module 3.2.P.8 stability text from these analytical results" 22 Suggest ICH Q1A compliant stability protocols Automatically create comprehensive stability testing protocols that meet international regulatory requirements. "Create 6M/12M/24M storage plan for this extended-release formulation" 23 Check manufacturing processes for compliance gaps Identify potential regulatory issues in process descriptions before submission to health authorities. "Review this manufacturing description and identify missing control points" 24 Generate control strategy tables for submissions Create comprehensive tables outlining critical process parameters, in-process controls and final product tests. "Create a control strategy table with CPP , IPC, and FP tests for this injectable" 25 Create comparative CMC tables for post-approval changes Generate side-by-side comparisons highlighting differences before and after manufacturing changes. "Generate a pre vs post-change summary table for this formulation adjustment" Sharan Murugan
- 9. Safety & Pharmacovigilance 26 Summarize PSUR/PBRER data for submission GPT-5 can analyze and condense large safety datasets into concise, submission-ready overviews for regulatory authorities. "Generate a concise executive summary from Q3 PSUR data highlighting key signals" 27 Draft DSUR safety updates from SAE reports Automatically compile Development Safety Update Reports using serious adverse event data from clinical trials. "Create DSUR section 7 using Q2 SAE database export" 28 Flag adverse event trends from case narratives Utilize AI text mining capabilities to identify patterns and emerging safety signals from unstructured case reports. "Analyze last 100 cardiovascular event narratives for common patterns" 29 Format RMP according to EMA template Generate fully structured Risk Management Plans following precise European Medicines Agency formatting requirements. "Format our existing risk data into EMA's latest RMP template structure" 30 Translate safety documents to required languages Convert critical safety information into multiple languages while maintaining regulatory terminology accuracy. "Translate this DHPC from English to all EU-27 languages while preserving technical terms"
- 10. Communication with Authorities 3 1 Draft response letters to HA queries GPT-5 can generate comprehensive responses to health authority queries combining technical details with regulatory justifications. "Draft response to FDA's CMC query on stability data" 32 Create briefing books for pre-submission meetings Generate well-structured briefing documents with key talking points for regulatory authority meetings. "Prepare FDA Type C meeting briefing book outlining our approach to pediatric studies" 33 Generate Q&A matrices from past authority queries Build searchable knowledge databases from historical interactions with regulatory authorities. "Create searchable Q&A database from our last three EMA scientific advice meetings" 34 Summarize inspection findings & CAPA Concisely present regulatory inspection observations and corrective/preventive actions for management review. "Create 1 -page executive summary of FDA Form 483 observations and our CAPA plan" 35 Suggest negotiation points for conditional approvals Develop risk-based arguments and strategic approaches for negotiating conditional marketing authorizations. "Propose negotiation strategy for EMA conditional approval based on our interim clinical data"
- 11. Post-Approval Lifecycle Management 36 Prepare variation filing checklists GPT-5 automatically generates comprehensive checklists for variation filings, categorizing them appropriately. "Generate Type IA, IB, and II classification checklists for EU market" 37 Draft renewals from initial application data Efficiently creates renewal applications by automatically updating and repurposing initial submission data. "Auto-generate EU renewal based on original MAA with updated safety data" 38 Compare country requirements for renewals Creates comprehensive comparison tables of renewal requirements across different regulatory jurisdictions. "Generate table view comparing renewal requirements for US, EU, Japan, and Brazil" 39 Suggest optimal submission strategy for global roll-out Analyzes market conditions and regulatory frameworks to recommend the most efficient global submission approach. "Evaluate sequential versus parallel submission strategy for our oncology product" 40 Track expiry & renewal dates automatically Creates interactive dashboards to monitor and alert teams about upcoming registration expiries and renewal deadlines. "Generate dashboard with 12 -month advance warning for all product renewals"
- 12. Training & Knowledge Management 4 1 Create training modules for new RA hires GPT-5 can develop comprehensive onboarding materials for regulatory affairs professionals, including interactive modules. "Generate an eCTD basics course with module structure and key concepts" 42 Summarize complex guidelines for non-regulatory teams Convert technical regulatory documents into simplified training materials accessible to cross-functional teams. "Create layman's explanation of ICH Q9 quality risk management for manufacturing team" 43 Generate MCQ quizzes for SOP training Create assessment tools to verify understanding of standard operating procedures and regulatory requirements. "Create 20-question test based on our deviation management SOP with answer key" 44 Maintain searchable internal RA knowledgebase Develop and organize comprehensive regulatory knowledge repositories with intelligent search functionality. "Create indexed Q&A database from past health authority correspondence" 45 Convert SOPs into quick reference cards Transform lengthy procedural documents into concise, actionable reference materials for daily use. "Create 1-page cheat sheet summarizing our change control process workflow"
- 13. Process Automation & Efficiency 46 Extract data from PDFs & populate templates GPT-5 can automatically extract key information from PDF documents and transfer it into structured submission templates. "Extract stability data from PDF report and populate ICH template" 47 Automate tracking of HA query deadlines Set up intelligent alert systems for regulatory query response deadlines across different health authorities. "Create reminder system for all pending FDA Day-74 responses" 48 Standardize document naming conventions Ensure all regulatory documents follow consistent, region-specific naming formats for better organization. "Rename these files according to eCTD Module 3 naming convention" 49 Prepare meeting minutes from recordings Transcribe and summarize regulatory authority meetings into structured minutes with action items. "Transcribe FDA Type B meeting and identify all commitments made" 50 Create dashboards of submission status Generate visual tracking tools to monitor regulatory submission progress across multiple markets. "Create visual timeline of our EU, US, and APAC submissions for Q3" Sharan Murugan
- 14. Summary & Next Steps Key Benefits of GPT-5 in Regulatory Affairs Enhanced Efficiency Automates repetitive tasks across all 10 regulatory areas, reducing processing time by up to ~20to50% Improved Accuracy Reduces human error in document preparation, formatting, and submission validation Global Regulatory Compliance Seamlessly adapts to different regional requirements and updates across markets Knowledge Management Creates organizational memory of regulatory decisions and precedents Implementation Roadmap 1 Assess current regulatory workflows and identify priority areas 2 Start with quick-win applications like intelligence monitoring 3 Develop organization-specific prompts and templates 4 Train regulatory staff on effective GPT-5 interaction 5 Implement progressive automation across all 10 categories A phased approach focusing on high-impact areas first yields the best results Thank You Questions & Discussion Made with Genspark Sharan Murugan