Day 1 - October 21st
- Frits Stulp - Chairman of the Board, CTADHL
Status update on PMS
EMA’s latest developments
How involved are competent authorities?
PMS use cases
Moving PMS to digital variation
Automated PMS submissions through RIM or MDM
- Pravin Shelke - Senior Manager Regulatory Operations and Compliance Support, Advanz Pharma
Status update from European regulators on IDMP implementation in their region
Successes, pain points, and lessons to implement
Key timelines for further implementation
Plans for the future of IDMP
- Philipp Weyermann - Head of Unit Regulatory Assessment 2, Swissmedic
- Kwee-Lan Tan - Regional Regulatory Lead, Emerging Markets, Boehringer Ingelheim
With parliament having adopted the package in Q2 2024, what stage are we at with the Council’s adoption?
Can we expect formal adoption by the end of 2025?
Once adopted, what impact will there be for all pharmaceutical stakeholders?
- Craig Slattery - Assistant Professor, University College Dublin
- Sergio Napolitano - General Counsel and External Relations Director, Medicines for Europe
- Leading on from the previous discussion, take a deeper dive into the variations segment
What does the new update say and what does it mean for manufacturers?
How does the update impact regulatory strategy, operations and tools?
Practical tips for adhering to the update
- Balázs Lázár - Head of Global Regulatory CMC & Operation Department, Gedeon Richter
Take a deep dive into industry’s perspective on their IDMP journey
How are they coping with the regulatory nuances?
How are they ensuring data readiness?
Have there been any lessons from sub-standard quality data?
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
- Sheila Elz - Master Data Manager, Bayer
- Felix Spenkuch - Associate Director, Global Regulatory Information Management, BioNTech
How can AI be used to help streamline IDMP data extraction, standardisation and validation
Opportunities for identifying risks, minimising errors, and relieving workload
Associated risks and solutions
Current experiences of employing AI on IDMP data sets
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
With the new regulation ( (EU) 2021/2282) having come into force in January 2025, what do we know about the new regulation?
What does the regulation aim to achieve?
What implications are there for industry, regulators, and beyond?
Phased implementation – what applies to which companies and by when?
- Craig Slattery - Assistant Professor, University College Dublin
Latest update on the UK’s regulatory landscape for pharmaceuticals
Specific focus on Northern Ireland
What does this mean for labelling, packaging and supply chains?
How can industry active, or looking to get into, the area do to prepare and continue activity?
- Frits Stulp - Chairman of the Board, CTADHL
What exactly is TRS and how does it relate to regulatory initiatives like PRISM and Reliance programs
How does it impact the industry sponsor companies.
Where data and data standards fit in, such as IDMP
How does it change system infrastructure and process for shorter approval times and opportunities for accelerated submission types.
- Brooke Casselberry - Vice President - Advisory & Consulting, Epsita Inc
- Victoria Ignatovich - Director of CIS countries Regulatory Affairs Office, WORLD MEDICINE ILAC, TÜRKİYE
With Step 2 of the implementation happening from May 2025, what have we already learnt from Step 1?
How is policy scope expected to be extended in Step 2?
What does the restart and implementation of this policy mean for clinical trial transparency?
How will this change the way in which teams collaborate?
- Anna Hanzlíková - Senior Director, Global RA, Regulatory Head, Europe and ROW, NOVAVAX CZ a.s.
With the drive towards cloud submissions, what options are on the market?
How do Accumulus and Project PRISM compare?
Key similarities and differences
Opportunities with cloud submissions, role of data, and future outlook
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Lucie Svobodová - Senior Manager, Regulatory Affairs, Novavax
Wondering what’s next for IDMP in Europe? Want to get the lowdown on the latest regulatory initiatives? Or interested in how industry can get involved in more upcoming projects? Take the chance to get your burning questions answered from our panel of regulators
- Abebe Alamneh, B Pharm, MSc, - Senior Medicine Registration Expert, Ethiopian Food and Drug Authority (EFDA)
- Isabel Chicharo - Head of Regulatory Data Management Service, EMA