Day 3 - October 24th 2024 - CET/CEST (Cent Europe Summer, GMT+2)
Day 3 - October 24th 2024 - CET/CEST (Cent Europe Summer, GMT+2)
- Luisa Heesen - Business Data Domain Owner Products and Substances, Boehringer Ingelheim
- Shortage management in the EU: ESMP in the regulatory landscape
- Current timeline for implementation and roll out
- What can industry expect from the platform?
- How will regulatory data feed into the platform and which data is expected?
- Sofia Zastavnik - ESMP Product Owner, European Medicines Agency (EMA)
- Final update on the UNICOM project
- Findings from the last 5 years
- Changes or updates to standards as a result of UNICOM
- Wider impact on patients and public health
- Life beyond UNICOM: what can industry expect?
- Christian Hay - Sr Advisor Healthcare, GS1 Global Office
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- Key data points when undergoing enhancement of RIM capabilities
- Pros and cons of RIM enhancement
- Impact on regulatory department and wider impact
- Gaining internal buy in
- Digitalization aspect
- Maturing digitized operating model
- Shaping digitized environment
- Impact on wider digital transformation
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
- Understanding set up and intention
- Results of Phase 1
- Use cases currently in testing
- Outlook
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Latest updates from Accumulus Synergy
- Current status of cloud based technology
- Industry interaction and current pain points
- Latest updates and developments
- The future of cloud: is there no turning back?
- Dominique Lagrave - VP of Regulatory Innovation, Accumulus Synergy
- Latest regulatory requirements for data collection in APAC
- Alignment between countries and Europe/US
- Acceptance of real world evidence (RWE)
- Working example: sufficient data collection in relation to APAC regulations
- Tips for sufficient collection
- Latest regulatory requirements for data in MENA & alignment with other regions
- Available resources and contacts in the region
- Common pitfalls and how to avoid for industry
- Current use case: where has AI/ML currently been implemented?
- Which processes is it supporting?
- Which regulations is it adhering to?
- Teething problems and solutions
- Future use cases
- What opportunities are there for AI/ML?
- How can other companies leverage similar approaches?
- Overview of pharma use case implementations enabled by IDMP-O
- Utilizing IDMP Knowledge Graphs with AI to speed up regulatory processes
- Learnings from the IDMP-O Maturity Benchmark Survey: What's needed to be successful with IDMP as a semantic product data backbone?
- Heiner Oberkampf - CEO and Co-Founder, Accurids
II. Case Study 1: The Role of Artificial Intelligence in Translation
A. Generative-AI as a Solution for Multilingualism in Europe and Beyond
- The Concept and Impact of Suggestive Translations
B. Impact of AI on The Industry
- Improving the Efficiency of Translation vs Potential Mistakes
- Job Security Concerns: The Risks of AI to Human Roles
- Future Perspectives: Expansion of AI in Translations and Its Impact on Global Submissions
III. Case Study 2 Leveraging Generative AI for Dossier Writing
A. The Rising Importance of Generative-AI in Pharma
- Opportunities for Simplifying the Dossier and Submission Process
- Section Writing
- Responding to Questions from Regulators
- Risks Involved in Using Generative-AI in Dossier Writing
- Rakesh Neelam - Sr Specialist- Digital Innovation & Systems - Regulatory Planning & Publishing, MSD
- Current data requirements in LATAM
- What’s new?
- Does each country align?
- Adhering to requirements
- Best practices for regulators
- Resources and contacts for industry
- Yuricel Tamayo Alvarez - Regulatory Affairs Specialist, Roche Ecuador S.A.
- Luisa Heesen - Business Data Domain Owner Products and Substances, Boehringer Ingelheim
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- With further digitalisation on the horizon, what does the next 5 years hold for RIM?
- Use of AI
- Tool development
- Workforce skills
- Regulatory needs
- Abita Nanda - Chapter Lead, Regulatory Innovation and Sustainment, Genentech
- Ana Montoya Alarcon - Strategic Business Partner Director - Regulatory, Novartis
- Andrea Fischer - Global Head Regulatory Operations – IT Systems & Digital, Sandoz
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- With eCTD 4.0 being adopted more widely, what is next for submissions?
- Can industry expect further amendments or versions to specifications?
- How do regulators see future alignment of specifications?
- How can stakeholders further collaboration to enhance working best practices?
- How do manufacturers prepare and upskill teams to meet the changing landscape of submissions?
- How much more entwined will submissions and RIM become?
- Anna Sokołowicz - Director, e-Submission Strategy and Process, GSK
- Teresa Eastwood-Kiefer - Regulatory Data and Content Chapter Leader, Roche
- Rakesh Neelam - Sr Specialist- Digital Innovation & Systems - Regulatory Planning & Publishing, MSD
- Alan Chalmers - Owner, Pharma International
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- Can we expect enhanced regional alignment for data requirements in the future?
- Can industry utilise the same data across regions?
- How can indsutry and regulators work together to improve data collection and submissions?
- Danini Marin - International Consultant, Pan American Health Organization