Day 2 - CET/CEST (Cent Europe Summer, GMT+2)
Day 2 - CET/CEST (Cent Europe Summer, GMT+2)
- Patrick Middag - IRISS IDMP Topic Group Lead, Deloitte
- Where does RIM sit in the bigger picture? A cross-functional data journey and beyond
- Approach from a document to data-driven organization
- RIM, data and AI vision for 2030
- Marina Schlepper - Senior Manager, Regulatory Compliance & Regulatory Information Management, Merck
- Update on web-based eAF implementation
- Form for variations
- Drivers for the release timeline
- Integration of Product Management Service (PMS) in eAF
- Industry adoption
- Successes and challenges
- Alastair Nixon - Director, Publishing, GlaxoSmithKline Research & Development Limited, UK
- Kristiina Puusaari - eSubmission Programme Coordinator, eAF Product Owner, EMA
- Noel Diamant - Product Owner, European Medicines Agency (EMA)
- Veronica Lipucci Di Paola - SPOR Master Data Manager, EMA
While pharmaceutical industry is ramping up digitally there has been a significant shift towards data-driven decision-making. It is revolutionizing the pharmaceutical industry by providing near real-time awareness of the overall health of the regulatory portfolio across all levels. This abstract explores the significance of data-driven approaches in regulatory portfolio management, highlighting how they enable proactive monitoring, informed decision making, and enhanced regulatory compliance. Managing a regulatory portfolio in the pharmaceutical industry involves overseeing numerous submissions, approvals, labeling updates, and post-approval commitments. Traditionally, this process relied on manual tracking and reporting, leading to delays, inefficiencies, and potential compliance risks. However, with the availability of vast amounts of data and advanced analytics capabilities, companies are now leveraging data-driven decision making to gain insights into their regulatory portfolio in near real-time. By integrating data sources and leveraging advanced analytics, pharmaceutical companies can generate dashboards and reports that offer a comprehensive view of submission statuses, approval timelines, labeling compliance, and post-approval commitments. This near real-time awareness empowers stakeholders to identify potential bottlenecks, prioritize resources, and take timely actions to address issues. Additionally, data-driven insights aid in informed strategic planning and resource allocation, allowing companies to anticipate regulatory requirements and allocate resources efficiently. Data-driven decision making enhances regulatory compliance by providing visibility into potential risks and deviations. Companies can monitor compliance metrics such as regulatory commitments, labeling updates, and adverse event reporting, enabling proactive risk management and timely corrective actions. Furthermore, data-driven approaches foster a culture of continuous improvement and agility in regulatory portfolio management. Analyzing performance metrics and comparing them against benchmarks enables companies to identify areas for improvement, set goals, and track progress, resulting in optimized processes and higher operational excellence. In this session, we will talk about how data-driven decision-making transforms regulatory portfolio management by providing near real-time awareness. and allows stakeholders to effectively monitor and manage the regulatory portfolio, leading to streamlined processes, faster approvals, and better regulatory outcome.
- Vartika Pandya - Manager R&D (Strategy, Insights and Planning), ZS Associates
- Heiner Oberkampf - CEO, Accurids
- Current status of eCTD v4.0 after 13 years of development
- eCTD v4.0 – What is it?
- Major enhancements and benefits
- Transition from eCTD v.3.2.2
- ICH Implementation package
- Supplemental documents
- Regional implementation plans and timelines
- Start of voluntary / mandatory use in the different regions
- Technical pilots
- First experiences after adoption
- Forward thinking
- What does the next 5 years of eCTD look like?
- Future eCTD technical specification and standards development (RPS, FHIR, …)
- Start development of Next Generation eCTD to address future business needs
- Bernd Misselwitz - Senior Director, Regulatory Submissions, Bayer
- Impact of implementing eCTD 4.0 on current processes
- Documentation
- Organizational structure
- Collaboration with all stakeholders: agencies, vendors
- Outcome
- Benefits of implementation
- Pitfalls to be aware of
- Tim Powell - Director, Submission Sciences, Biogen
- Bernd Misselwitz - Senior Director, Regulatory Submissions, Bayer
- Alan Chalmers - Director, Pharma International
- Challenges that arise from regional interpretations of ICH guidance
- Identifying areas of divergence
- Overcoming country specific control strategy
- Plans for the future
- The ICH Q12 case
- Alessandra Leone - Global CMC Senior Manager - I&I, Pfizer, Italy
- Selecting the right regulatory pathway
- Key cultural challenges
- How to work with the NMPA
- Opportunity of convergence with other nations
- Stefano Accorsi - Head of Global Regulatory Intelligence and Policy, Chiesi Farmaceutici
- PLM Data Readiness for CAPs and the close relationship to xEVMPD
- Leveraging the IDMP Operating Model
- Data remediation and data support for Regulatory Data Owners for initial go live of web based eAF
- User Access Management and training for users
- Preparing for future
- Variations for non-CAPs and beyond
- Sandra Broderick - Head of Structured Data Strategy, Sanofi
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Vada A Perkins - Executive Director, Regulatory Policy & Innovation, Bayer
- Patrick Middag - IRISS IDMP Topic Group Lead, Deloitte
- Combining Regulatory landscape changes with company’s internal transformation
- New Web PLM-eAF readiness, RIM upgrade & RDM/MDM deployment
- Data Readiness through Process, System and Governance
- Implementing innovative Training & Communication platforms
- Use multiple communication channels and formats
- Establish dedicated training platforms and tools
- Focusing on the Business impact
- What’s changing: internal benefits
- Roadmap for a smooth implementation
- Early awareness and issues identification
- Relevant Point of contacts for support
- Jean-Michel Cahen - IDMP Project Lead – RA Operations, Novartis Pharma AG, Switzerland
- Development of FHIR standard
- Where does it fit with regulatory operations?
- FHIR Standards for ePI and CMC
- Adaptions of FHIR across Europe and the globe
- Impact on industry of regional nuances
- Considerations for implementation
- Craig Anderson - Director, R&D Labeling Lead, Pfizer
- IDMP implementation overview
- How does IDMP fit across the regulatory landscape?
- Effects of IDMP implementation on the regulatory procedures
- Beatriz Ugalde - Regulatory Data Manager, Asphalion
- Industry case study of submitting in China
- Key dossier components
- Common questions by China Center for Drug Evaluation (CDE)
- Procedure alignment with both EMA and FDA
- Key differences and things to watch out for
- Best practices for submission
- Lifei Wang - Director, Submission Operations Management, BeiGene
- Status of eCTD 4.0 implementation in EAEU
- Challenges to implementation
- Expected mass adoption date in region
- Impact on industry
- How can industry prepare if they’re wanting to submit within EAEU?
- Contacting and working with local partners
- Maryana Novozhenyuk - Global Regulatory Affairs CMC Manager, Bayer
- Heiner Oberkampf - CEO, Accurids
- Introduction to Accumulus synergy and status update
- Cloud technology considerations, applicability and challenges to regulatory innovation
- Current Engagement and future opportunities
- Dominique Lagrave - VP of Regulatory Innovation, Accumulus Synergy
- Working collaboratively
- Combining quality and regulatory skills for product release
- Lifecycle management on a global scale
- Consolidating regulatory dossiers
- Opportunities for this working methodology
- Olivier Lechien - Regul@OLi Pharma Consulting, ex GSK/ Thermo Fisher Scientific, more than 25 of years of Regulatory Affairs experience., .
- Current status of ICH adoption across the region
- Successes
- Pain points
- Future plans for wider adoption
- Christina Juli - Head of CMC Management CMB, Boehringer Ingelheim
- Implementation status in Saudi Arabia
- Challenges with implementation
- Priorities for 2024
- Adoption across wider Middle Eastern Region
- Abdulaziz Albesaily - Regulatory Affairs Manager, Sudair Pharmaceutical Company
- Christina Juli - Head of CMC Management CMB, Boehringer Ingelheim
- Status of adoption across the region
- Impact on industry, regulators and vendors
- Difficulties with regional and global harmonisation
- Key considerations moving forward
- Gustavo Mendes Lima Santos - Director of Regulatory Affairs, Quality and Clinical Trials, Fundacao Butantan
- Pedro Franco - Director Europe for Global Regulatory & Scientific Policy (GRASP), Merck Serono
- ICH’s priorities for 2024 and plans for further global adoption
- Countries under consideration
- Perceived challenges with adoption
- Country readiness
- Common hurdles to overcome
- Gustavo Mendes Lima Santos - Director of Regulatory Affairs, Quality and Clinical Trials, Fundacao Butantan
- Alessandra Leone - Global CMC Senior Manager - I&I, Pfizer, Italy
- Faraat Ali - Manager, Department of Inspection and Enforcement, Laboratory Services, Botswana Medicines Regulatory Authority (BOMRA)
- Pedro Franco - Director Europe for Global Regulatory & Scientific Policy (GRASP), Merck Serono
- EU CTR/CTIS background
- Navigating to CTIS – Usability, challenges, and data linkage (SPOR, xEVMPD)
- Business process flow – Document, Data & HA Interaction Tracking
- Readiness and use of the Sponsor RIM system
- Lesson Learned (User experiences)
- Shakul Hameed - Director, Global Regulatory Affairs Operations, Horizon Therapeutics Austria GmbH
- Defining data points across multi-departmental teams
- Clinical, regulatory, quality & safety
- Feeding this data into end-to-end processes
- Using data to inform internal and external decisions
- Improving working practices
- Opportunities for businesses
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
- Cedric Berger - Head of Knowledge Extraction and Integration, Roche
- Akira Yamaguchi - Chief Technology Officer, LORENZ Life Sciences Group
- Successes and challenges from varying company sizes
- Team roles
- Dossier compilation best practices
- Differences in experience of small vs medium vs large companies
- Lessons learned from previous submissions
- Future considerations
- David Donne PhD - Vice President and Oncology Regulatory Affairs Group 2, Bayer
- Dominique Lagrave - VP of Regulatory Innovation, Accumulus Synergy
- Beverly Chin - Senior Regulatory Submission Manager, Genentech
- Lifei Wang - Director, Submission Operations Management, BeiGene