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Day 3 - CET/CEST (Cent Europe Summer, GMT+2)
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Day 3 - CET/CEST (Cent Europe Summer, GMT+2)
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08:30 - 09:00
Conference Registration
Showing 3 of 3 Streams
Regulatory Information and Data Management Initiatives
Global eSubmissions
Regulatory Affairs in Global Markets (Digital Only)
09:00 - 09:10
Chair’s opening remarks
- Luisa Heesen - RIM Manager, Boehringer Ingelheim International GmbH
09:10 - 09:40
Approaches to Leveraging AI in RIM Transformation
- AI tools available for RIM enhancement
- Positives of AI
- Efficiency
- Safety
- Accelerated market entry
- Challenges
- Data protection
- Quality concerns
- Costs
- Considerations for future use
- Raj Patra - IT&D Product Group Head – Quality & EHS, Supply, Reckitt
09:40 - 10:10
Case Study: The Five Stages of Grief over Changing RIM Processes
This session will present BeiGene’s recent experiences and challenges in modernizing their content management and RIM Registrations. This will include such topics as:
- Overcoming the limits of imagination of the vendors to support a small company that doesn’t just go after the major markets
- Gaining consensus when teams are scattered across three continents, two product lines, two therapeutic areas, and seven functional areas
- Mounting archaeological-like expeditions to uncover and interpret spreadsheets for integration and migration
- Joel Finkle - Associate Director, Regulatory Information Management, BeiGene, Ltd
10:10 - 10:40
How Modern Rendering Can Automate Beyond the Creation of PDFs
Learn how you can leverage modern rendering capabilities to automate many additional use cases. Some practical examples:
- Prepare multiple compliant global PDF renditions simultaneously.
- Generate regulatory and other corporate reports (merge, bookmark, add ToCs, cover pages, pagination and other overlays to your single or multi-PDF output).
- Identify and fix technical and formatting issues for Word and PDF content.
- OCR your content to ensure it is text searchable (and compliant).
- Process incoming email messages to be stored in your repositories with or without attachments (correspondence & other).
- Conversions to non-PDF formats (html, image formats, audio/video, docx, xlsx, etc)
- Prepare content for longer term archive platforms (PDF/A, TIFF, etc. formats)
- Help migrate content from one repository to another.
- Geert Van Peteghem - CEO, DocShifter
10:40 - 11:10
Networking Break
11:10 - 11:40
Back to Basics: Data Governance
- Defining data governance
- How does this fit into IDMP and RIM
- Case study of setting up governance framework
- Link to IDMP processes
- How to scale framework
- Ensuring adaptability
- Eileen Connolly - Executive Director, Head of Regulatory Affairs CMC, Jazz Pharmaceuticals
11:40 - 12:10
Implementing an Effective Master Data Strategy in Regulatory Affairs
- The basis for Master Data
- Data sources beyond RA
- Cross-departmental data flow and processes
- Luisa Heesen - RIM Manager, Boehringer Ingelheim International GmbH
12:10 - 12:40
Electronic Product Information (ePI): Where Are We Now?
- Development status
- Current progress
- Harmonised implementation
- Next steps
- Impact for industry
- Link to big data
- Foreseen limitations
- Limitation of medicinal supply exchange
- Geraldine Lissalde-Bonnet - Vice President Healthcare, GS1 Global
12:40 - 13:40
Lunch
13:40 - 13:45
Chair’s afternoon remarks
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
13:45 - 14:30
Elabelling: The Future of Labelling
- Current labelling preferences across the globe
- Who is accepting of digital labelling?
- Types of digital labelling
- Weighing up the benefits
- Accessibility
- Affordability
- Accurate information documentation
- The future of labelling for the next 10 years
- Koen Nauwelaerts - Regulatory Policy and Innovation Lead, Bayer
14:30 - 15:00
Digitalization, One of the 5 Levers to Bring Your RA Model to the Next Level
- Jean-Luc Taborin - VP, Head of Consulting, ProductLife Group
- Gregoire Mouton - RIM Team Lead, ProductLife Group
09:00 - 09:10
Chair’s opening remarks
- Dominique Lagrave - VP of Regulatory Innovation, Accumulus Synergy
09:10 - 09:55
Project Orbis: A New Way to Collaborate?
- Project Orbis – what is it?
- Stakeholders involved
- Current status of project
- Benefits vs challenges
- Sharing of workload
- Expedited drug approvals
- Future of collaborative initiatives
- Aurélie Kam - Head of Global Business Unit (GBU) Submission Management, Sanofi
09:55 - 10:25
Accelerating Lifecycle Variations with Process Optimization
In this session, we'll review how biopharma companies can leverage a unified regulatory system to:
- Optimise regulatory processes to achieve consistent and efficient delivery
- Leverage a core package to streamline global operations
- Design an organizational model that reduces cycle times
- Automate time-consuming tasks to further improve outcomes
- Paul Attridge - VP Vault RIM, Enterprise, Veeva Systems
- Kim Brownrigg - Regulatory Practice Manager, R&D Business Consulting, Veeva Systems
10:25 - 11:10
Networking Break
11:10 - 11:55
Industry Case Study: Submitting under Project Orbis
- First-hand experience of drug approval under Orbis
- Timelines
- Example documentation
- Common questions from agencies
- Lessons moving forward
- Beverly Chin - Senior Regulatory Submission Manager, Genentech
- Amy Keum - Regulatory Submission Manager, Roche
11:55 - 12:40
Unlock the Data from your Dossiers
- Instant Regulatory impact assessment across products, dossier types and regions
- Instant document comparison across versions, products, dossier types and regions
- Instant translation of any document
- Ability to see data, documents and dossier connected
- Michiel Stam - Director Regulatory Information Management, Celegence
12:40 - 13:40
Lunch
13:40 - 13:45
Chair’s afternoon remarks
- Dominique Lagrave - VP of Regulatory Innovation, Accumulus Synergy
13:45 - 14:30
Determining the Intersection between eCTD and IDMP
- Where do eCTD and IDMP meet?
- How does increasing product data impact eCTD dossiers?
- Can industry be proactive in creating documents which adhere to both?
- Pitfalls to watch out for
- Future considerations for industry and agencies
- Tim Powell - Director, Submission Sciences, Biogen
- Alastair Nixon - Director, Publishing, GlaxoSmithKline Research & Development Limited, UK
14:30 - 15:00
A Guide for Smaller Enterprises: Bringing eCTD Publishing In-house
- How to know it’s time to move publishing in-house
- Questions to ask potential vendors
- Ensuring the success of those critical first submissions – ensuring staff are supported
- Future scalability considerations
- Sandra Vignes - Technical Solutions Director, Calyx
09:00 - 09:10
Chair’s opening remarks
- Alan Chalmers - Director, Pharma International
09:10 - 09:40
Biosimilar Regulations in the MENA: Saudi Arabia, Jordan, Iraq & Egypt
- Current regulatory requirements for biosimilars in MENA
- Comparison to EMA and FDA
- Current challenges
- Updates on the horizon and impact for industry
- Khalid Al-Kinani - Head of the Biologics and Biosimilars Registration Committee, Iraqi Ministry of Health
09:40 - 10:25
Strengthening Regulatory Systems for ATMPs in Brazil
- Initiatives launched by ANVISA
- Comparison: Brazil vs global regulations
- Expected developments
- Lilian Gonzalo - Senior Regulatory Affairs Manager, Novartis
- Leandro Lozano - Senior Consultant and Owner, RegStrat
10:25 - 11:10
Networking Break
11:10 - 12:40
Biosimilar Regulations in LATAM
- Variation of biosimilar regulations across the region
- Impact on industry in light of variations
- Best practices for adhering to nuances
- Forward thinking
- Can these be harmonised?
- Thomas Kirchlechner - Director Regulatory Policy & Intelligence, Sandoz
- Yuricel Tamayo Alvarez - Regulatory Affairs Specialist, Roche Ecuador S.A.
12:40 - 13:55
Lunch
13:55 - 14:00
Chair’s afternoon remarks
- Khalid Al-Kinani - Head of the Biologics and Biosimilars Registration Committee, Iraqi Ministry of Health
14:00 - 14:45
E-Labelling Implementation in Brazil and Across Latin America
- Urimara Argotti - Regional Regulatory Policy Manager for LATAM – PDR, Roche
- Mariana Ramirez - Regulatory Affairs Specialist, Roche
14:45 - 15:15
eLabelling Initiatives in APAC
- Current initiatives across the region
- Most accepting markets
- Hurdles to consider
- Enhancing eLabelling in the region
- Plans for further roll out
- Jianhui Sun - Regulatory Affairs Manager APAC Region, SEPTODONT
15:15 - 15:45
Networking Break
Showing 3 of 3 Streams
Regulatory Information and Data Management Initiatives
Global eSubmissions
Regulatory Affairs in Global Markets (Digital Only)
15:45 - 16:45
Industry Case Study: The Future of the Regulatory Workforce
- In the digital era, how will the regulatory role change?
- Influence of automation
- Which skills will become most desirable?
- Creating a workforce which is future-proof
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
- Vanni Carapetian - Regulatory Data Capability Lead, Genentech
- Cedric Berger - Head of Knowledge Extraction and Integration, Roche
- Anne Bourrelly - Regulatory Innovation & Sustainment Leader, Roche
15:45 - 16:15
Documents: A Thing of the Past?
- With a large focus on the future of submissions, can we forget about documents?
- To which extent should companies continue to focus on PDFs and their needed improvements?
- Tradeoff between investing in improving old processes vs implementing new systems
- Improving submission experiences
- Link between improving documentation processes, team efficiency and submission outcomes
- Forward thinking once current processes are secured
- Matt Neal - Senior Director, Regulatory Affairs Operations, Atarabio
16:15 - 17:00
Big Picture Panel: The Future of eCTD and Beyond
- What is next on the horizon for eCTD?
- How is the EMA preparing for further adoption by other agencies?
- How can industry help with adoption of further agencies?
- Challenges for eCTD adoption
- Influence of geopolitical factors
- Roadmap for the next 10 years
- Dominique Lagrave - VP of Regulatory Innovation, Accumulus Synergy
- Teresa Eastwood-Kiefer - Regulatory Data and Content Chapter Leader, Roche
- Bernd Misselwitz - Senior Director, Regulatory Submissions, Bayer
15:45 - 16:15
eLabelling in Middle East & Africa
- Implementing elabelling in MENA market
- Key considerations
- Common pitfalls
- 2024 priorities
- Abdul Mateen - Director, Healthcare Consultancy Services, UK
17:00 - 17:05
End of Conference
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