Day 1 - October 22nd 2024 - CET/CEST (Cent Europe Summer, GMT+2)
Day 1 - October 22nd 2024 - CET/CEST (Cent Europe Summer, GMT+2)
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- How far ahead is IDMP implementation within Europe?
- Current regulatory framework
- Available guidance and resource
- Next steps for IDMP in Europe
- Future collaboration with other global regulators and alignment of frameworks
- Laurent Desqueper - Director Regulatory Affairs in Regional Regulatory Operations EMEA, Merck Sharp & Dohme (MSD)
- Isabel Chicharo - Head of Regulatory Data Management Service, EMA
- Status update on IDMP in Switzerland & UK
- How closely aligned to EMA’s implementation strategy and framework are they?
- Working groups’ current priorities
- On-going digitalisation work
- The next 5 years of IDMP in non-EU countries
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
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
- Areas of reform
- The changes in the DE system compared to the current legislation and its impact on the pharmaceutical companies
- Current implementation timelines
- When will the legislation become mandatory?
- Implementation and adherence practicalities
- Are competent authorities aligned on expectations?
- How can industry prepare for 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
- Lessons learned from other industries
- How Regulatory sandboxes can help foster innovation
- With reliance being a consistent conversation, what progress has been made to date?
- Which countries share reliance pathways?
- Has this increased work sharing?
- Are pathways more efficient?
- Wider impact
- Industry's workload
- Medicine availability
- Next steps for reliance
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
- vocabularies are being used?
- How do they align with the ISO?
- How closely aligned are they with EMA’s version of IDMP and further regions?
- Practicalities for manufacturers
- Will data differ greatly to align with FDA & Health Canada’s standards vs EMA’s?
- Best practices for improving global IDMP data and utilising in submissions
- Identifying which PQ/CMC data would benefit from structured submission approach
- Placement of the information in Common Technical Documentation
- Progress to date and next steps
- Update on workplan and associated timelines
- Which stakeholders are involved?
- Can industry get involved? And, if so, how?
- Detailing the 4 key areas on the workplan
- Proposed benefit for regulators, industry and wider public health
- Latest Advancements on reliance and convergence in APAC
- Current available pathways by country
- Comparison to other regional pathways
- Success story: utilising reliance for approval
- Lessons learned and future implications
- Latest regulatory updates for reliance pathways in the Middle East and Africa
- Impact of such pathways on medicines available in the region
- Current experiences with using reliance pathways
- Challenges and opportunities
- On-going work
- Future plans for further development
- Abdul Mateen - Director, Healthcare Consultancy Services, UK
- Khalid Al-Kinani - Head of the Biologics and Biosimilars Registration Committee, Iraqi Ministry of Health
- Latest updates of ICH M4Q from the working group
- Outcomes from multi-stakeholder consultation
- Current focuses and on-going work
- Applications for industry
- Is it compulsory?
- The future of ICH M4Q
- Laurent Lefebvre - Regulatory CMC Director, Novartis Pharma AG
- With multi-country IDMP initiatives coming to fruition, what are the opportunities and challenges for industry:
- Managerial support
- Investment in IDMP
- Data and process readiness in line with other data sets
- Moving forward
- Company's plans for further work
- Areas for regulators to address
- Laurent Desqueper - Director Regulatory Affairs in Regional Regulatory Operations EMEA, Merck Sharp & Dohme (MSD)
- EU-X-CT Multi-Stakeholder Initiative - Scope
- Cross-Border Access to Clinical Trials - Status Quo and Interim Results
- Call for Action
- Darius-Jean Namdjou - Head of Regulatory Affairs & Pharmacovigilance, Immunic Therapeutics
- What are the current environmental regulatory requirements for manufacturing and distributing pharmaceuticals in Europe?
- How are regulators and industry helping to reduce environmental impact?
- Tracking carbon footprints of shipments, manufacturing, etc...
- Limiting plastic use and increasing reusable materials
- Global initiatives focusing on sustainability
- Ways to get involved
- Upcoming projects
- 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
- Putting reliance principles into practice: Ins and outs of the WHO prequalification (PQ) and collaborative registration procedure (CRP)
- Industry experience with PQ and CRP
- Thomas Kirchlechner - Director Regulatory Policy & Intelligence, Sandoz
- Current alignment status of reliance pathways across LATAM
- Comparison to other regions
- Experiences with gaining approval
- Next steps: how can further alignment be achieved?
- Diego Alejandro Gutiérrez Triana - Regional Regulatory Director - Colombia, Udela
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 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, Publishing, GlaxoSmithKline Research & Development Limited, UK
- EMA's migration approach: Rules and pitfalls
- Ways of comparing PMS with your internal data sources
- Results and conclusions
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
- The story behind the revision
- Updates in the framework
- Future outlook
- Alessandra Leone - Global CMC Senior Manager - I&I, Pfizer, Italy
- With legislative reforms on the horizon, how does the future look for pharmaceuticals in Europe?
- Expectations on industry
- Cross-regional harmonisation
- Availability of medicines
- Future-proofing workforces
- Which skills and tools do we expect to become more prevalent in the coming years?
- Can industry and regulators alike prepare for these changes now?
- How does the concept of reliance filter into work sharing and collaboration?
- Could cross-regional work sharing enhance medicine availability and reduce duplicated submission work?
- Future of the workforce
- Preparing teams for enhanced collaboration
- Organisational structuring for optimal working practices
- Faraat Ali - Manager, Department of Inspection and Enforcement, Laboratory Services, Botswana Medicines Regulatory Authority (BOMRA)
- Céline Bourguignon - Head, Greater China and Intercontinental & Emerging Markets Regulatory Policy, GSK