Day 2 - October 22nd
- Patrick Middag - Principal Regulatory Affairs Lead, Servier
Since the first full version release of ESMP in January 2025, how is the platform working?
Current experiences of use and initial feedback
Importance of accurate and standardised data for managing shortages
Link to IDMP data sets
How can stakeholders work together to increase shortage management efficiency and accuracy?
- Raj Patra - Global IT & Digital Lead - R&D, Safety, PLM, Quality, Regulatory Affairs & Compliance, Reckitt
- Isabel Chicharo - Head of Regulatory Data Management Service, EMA
Where are we with the latest revision for ICH M4Q?
Timelines and scope
What are the implications for industry and how can they prepare?
Link to SPQS and PQKM
- Laurent Lefebvre - Regulatory CMC Director, Novartis Pharma AG
As eCTD implementation continues to roll out globally, what are the biggest updates across the regions?
Which regulatory authorities are next in line to implement 4.0?
How are authorities aligning implementation and industry expectations?
Are any authorities looking beyond 4.0?
- Karin Markgraf - Head of Regulatory Affairs Asia Pacific, Merck Group
Deep dive into industry's’ experiences of using eCTD in different regions
How do expectations differ country by country, or region by region?
Current opportunities and places for refinement
- Karin Markgraf - Head of Regulatory Affairs Asia Pacific, Merck Group
- Konstantin Koshechkin - Head of eSolutions Department, Inpharmatis Group
International status of global identifiers
Moving on from end-to-end showcasing into piloting
Who is involved?
Can others get involved?
Link to CTADHL
Current findings and plans for next steps
- Frits Stulp - Chairman of the Board, CTADHL
- Malin Fladvad - Product Portfolio Officer, Uppsala Monitoring Centre
Breakdown of current substance registration and data streamlining initiatives
How do they differ between EU, US, and other global regions?
Can industry streamline data to be suitable for both systems?
Future of substance management
- Marcel Hoefngel - Assessor, Biopharmaceuticals, College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)
As cross-functional data filters more and more into submissions, how can we enhance collaboration between departments?
How closely are IDMP and eCTD teams currently working together?
Where is the obvious crossover for collaboration?
What are the current learnings from teams which have started working more closely?
How can industry work with regulators to resolve these silos further?
- Suzie Henderson - Associate Director, Regulatory Affairs, Shionogi Europe
What are the current regulatory guidelines and requirements for using RWE in regulatory submissions at EU and UK level?
How are RWE data sources being used by all stakeholders?
Discussion of the Joint EMA/HMA Big Data Steering Group and DARWIN-EU
How can RWE initiatives be taken further to estimate appropriate timelines for submissions by industry and reactions by regulators?
- Sarnali Mitra Malwade - Principal-Regulatory Affairs, Eli Lilly & Co
Differentiating between master data management and regulatory information management
When to use which and which systems to implement
Importance of effective master data management
Impact on other data and regulatory operation processes
Tips for enhancing efficiency
- Filip Cvetanovski - Regulatory Affairs, ALKALOID AD Skopje
With continuously evolving submission processes and data requirements, how can industry balance all requirements when finalising submissions?
Link to European Health Data Space (EHDS)
How do the latest eCTD developments link to emerging data standards?
How can you bring this together to streamline submissions?
How can industry leverage other initiatives, such as SPOR or ESMP, in submissions preparation?
- Scott Cleve - Vice President - Regulatory Operations, Information and Compliance, Daiichi Sankyo
- Marta Moretti - Senior Legal Counsel Europe, BeiGene Switzerland GmbH
Take the final 90 minutes of the day to deep dive into a breakout topic of your choosing. Lead by a select group of facilitators, explore the topics relating to AI, regulatory soft skills, and more...!
Viewing regulatory affairs as holistic, rather than siloed
Benefits and challenges
Setting up a project team
Stakeholders to involve
Curating inter-departmental relationships
How would this approach help in streamlining workload and enhancing submissions
- Kwee-Lan Tan - Global Regulatory Affairs, Boehringer Ingelheim
- Aline Mello Carolina - Regulatory Project Manager, Boehringer Ingelheim
Take the final 90 minutes of the day to deep dive into a breakout topic of your choosing. Lead by a select group of facilitators, explore the topics relating to AI, regulatory soft skills, and more...!
With the rise in AI, which tools and techniques are there to help with submission prep?
What are the opportunities and risks associated with using AI to generate and populate data?
Can these be mitigated?
Example of successful use of AI in submission completion
- Sebastian Fischer - Regulatory Strategy Principal, TÜV SÜD Product Service GmbH
Take the final 90 minutes of the day to deep dive into a breakout topic of your choosing. Lead by a select group of facilitators, explore the topics relating to AI, regulatory soft skills, and more...!
What is the relationship between regulatory data and corporate MDM?
Regulator's view vs industry’s
Supply chain
Legal
Commercial
How to determine who owns what
- Luisa Heesen - Business Data Domain Owner Products and Substances, Boehringer Ingelheim