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 regulatory update for eAF, timelines for implementation
- Recent modifications to form or upcoming amendments – renaming, copy, review/approval, status
- Industry's current experiences with completing forms in PLM portal
- Alastair Nixon - Director, Publishing, 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?
- GIDWG
- Governance
- Updates
- Global PhPIDs
- Where are we now?
- Challenges before go live
- Global substances
- Global collaboration on substances in different forums
- Where are we now?
- 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 - eSubmission Programme Coordinator, eAF Product Owner, 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
- Teresa Eastwood-Kiefer - Regulatory Data and Content Chapter Leader, Roche
- 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
- Defining and securing data for cross-departmental use within divisions and companies
- Utilising secured and defined data
- Submissions
- Automation
- Artificial intelligence
- Best practices for effective use of data flow maps
- Latest specification update on eCTD 4.0 in Ukraine
- Alignment with other regions
- Expectations for regulators and indsutry alike
- Experiences of submitting within the region
- Lessons for future implementation
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
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
- 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
- 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
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
- 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?
- Alan Chalmers - Director, 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?
- 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
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
- Alessandra Sech - Regulatory Manager, Sandoz
- How do we get data and documents closer together?
- Impact of closer alignment on regulators and industry
- Future of data & documents
- Remco Munnik - Vice President, IRISS Forum
- 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