Day 2 - October 23rd 2024 - CET/CEST (Cent Europe Summer, GMT+2)
Day 2 - October 23rd 2024 - CET/CEST (Cent Europe Summer, GMT+2)
- Latest proposals on process for using Web eAF to maintain PMS data
- How does PMS get updated on approval?
- Managing parallel variations
- Managing changes where no eAF is required
- Alastair Nixon - Director, Submission Standards, GlaxoSmithKline Research & Development Limited, UK
- Defining ‘global’ substance registration – is it actually global?
- How closely aligned are FDA and EMA’s initiatives?
- Current work by the FDA
- Current status of software development
- Current priorities of system development
- In Europe, what are the initial learnings from the EU-SRS roll out?
- Larry Callahan - Chemist, FDA, USA
- Marcel Hoefngel - Assessor, Biopharmaceuticals, College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)
- GIDWG
- GIDWGs role in the global IDMP landscape
- Updates
- Global PhPIDs
- Updates
- Global substances
- Global collaboration on substances, in different forums
- Where are we now?
- Olof Lagerlund - Substance Expert, Uppsala Monitoring Centre
- Current status of adoption throughout Europe: including UK and Switzerland
- On-going work: which countries are next in the pipeline?
- Upcoming revisions to eCTD
- How harmonised are already adopted countries?
- The future: is there a version beyond 4.0?
- Kristiina Puusaari - eSubmissions Programme Management, EMA
- how are countries in APAC and Africa adopting eCTD
- What is the state of play in countries such as China, Japan, South Korea and beyond?
- AMA & ECOWAS implementation progress
- Alignment in expectations
- How closely aligned are specifications in new eCTD countries comparing to major eCTD markets
- Moving forward: how is eCTD expected to develop in the different regions
- Anna Sokołowicz - Director, e-Submission Strategy and Process, GSK
- Teresa Eastwood-Kiefer - Regulatory Data and Content Chapter Leader, Roche
- Laura Valtere - Guest Lecturer, Riga Graduate School of Law
- With more focus being placed on rare diseases, what are APAC’s current regulatory requirements and pathways for market access?
- Current availability of advanced therapies in the region
- Comparison to other global regions
- Working example: gaining approval for advanced therapies in APAC
- Upcoming developments and future plans
- Anna Litsiou - Regulatory Policy & Intelligence Director - International & China, AstraZeneca
- Part 1: The Data flow map
- E2E data flow along the product lifecycle for selected business scenarios
- E2E data flow across systems and functions
- Delivering the visualized value chain of data
- Part 2: Overcoming Master data challenges when implementing a system platform approach across various functions
- Main challenges in a complex setting
- Real world examples
- Holistic oversight of a Data Integration Manager as key
- Luisa Heesen - Business Data Domain Owner Products and Substances, Boehringer Ingelheim
- Michael Kempf-Hamm - Senior Manager Data & Process Integration, Boehringer Ingelheim
- Latest specification update on eCTD 3.2.2 in Ukraine
- Alignment with other regions
- Expectations for regulators and indsutry alike
- Experiences of submitting within the region
- Lessons for future implementation
- Dmytro Lurye - Project Manager, Medicines for Europe
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
- Latest regulatory landscape for advanced therapies across MENA
- How aligned are pathways across the region?
- Expected timeline from product to patient
- Current challenges with approval
- Shaping the future
- Collaboration across countries and regions
- On-going development work
- Qutaiba Al Manaseer - Government Affairs Director, AstraZeneca
- Reviewing data governance within the organisation
- Strengths and weaknesses
- Strategy development process
- Key data points
- Incorporation of IDMP and RIM standards
- Future-proofing data governance strategies and processes
- Martin Steinmann - Sr Manager, Regulatory Data Management, CSL Behring
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
- Defining real world evidence
- Do definitions harmonisation across Europe and the US?
- Methods of collecting, storing and analysing RWE
- How do you ensure data is sufficient and support submission messaging?
- The future of evidence
- Can we expect further integration of this type of data into submissions?
- How can teams pivot to meet the demands of RWE and related submission changes?
- Jesper Kjær - Global Director for Public, Private Partnerships, StratOps, Global Medical Affairs, Novo Nordisk, Denmark
- Access to medicines – Explore how traceability supports inventory managment at various points in the supply chain.
- Access to Online Product Information (ePL) - Discuss methods to improve patient access to comprehensive product information online through electronic Product Information Leaflets (ePL).
- Single Unit Dose Packaging: Learn about the benefits of single-unit dosage packaging in enhancing medication adherence and safety for patients.
- Martin Fitzgerald - Director Digital Health and Public Policy Healthcare, GS1
- Geraldine Lissalde-Bonnet - Vice President Healthcare, GS1 Global
- 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
- Regulatory state of play across LATAM for rare diseases
- Are regulatory pathways aligned?
- Current approval timelines across the region
- Challenges with current approval pathways
- The future in LATAM: how can further alignment be achieved?
- Mario Alanis, PhD - Senior Advisor, CIRS - Centre for Innovation in Regulatory Science
- Filip Cvetanovski - Regulatory Affairs, ALKALOID AD Skopje
- Current status of FHIR Standards
- Impact on industry – is this compulsory?
- Working example: implementing the messaging format
- Once structured data has been generated, how are companies assessing readiness of XML messaging format?
- Points of assessment
- Tools used
- Lessons learned and best practices moving forward
- Craig Anderson - Director, R&D Labeling Lead, Pfizer
- With pilots of ePI ongoing, what experiences do we have so far?
- Interaction with EMA during pilots
- Initial learnings and anticipated modifications
- The next stage of ePI for industry and regulators
- Embedding for submissions and IDMP usage
- Global harmonisation expectations
- Digitalization
- Koen Nauwelaerts - Regulatory Policy and Innovation Lead, Bayer
- Anne Moen - Coordinator, Gravitate Health & Professor, University of Oslo
- Elizabeth Scanlan - Scientific Communication Officer & ePI Product Owner, European Medicines Agency (EMA)
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
- Alessandra Sech - Regulatory Operations Manager, Tiefenbacher Group
- How do we get data and documents closer together?
- Impact of closer alignment on regulators and industry
- Future of data & documents
- Remco Munnik - Chair of the Telematics Working Group, Medicines for Europe
- Frits Stulp - Chairman of the Board, CTADHL
- Analysing learnings from the day, how can regions enhance collaboration for advanced therapy regulation?
- What is needed to expedite these pathways?
- Future impact of enhanced collaboration
- Timeline from product to patients
- Wider public health
- Impact on manufacturers and regulators
- Belinda Mudhobhi - Pharmaceutical Innovation Strategy and Regulation Specialist, AfricaBio