Day 1 - CET/CEST (Cent Europe Summer, GMT+2)
Day 1 - CET/CEST (Cent Europe Summer, GMT+2)
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- With taskforces having been dissolved, how has industry been impacted?
- Is information readily available to industry?
- Review of EMA’s current demos
- Which solutions to meet requirements are being offered?
- Laurent Desqueper - Director Regulatory Affairs in Regional Regulatory Operations EMEA, Merck Sharp & Dohme (MSD)
- Now 2 years into this transition, what is the current state of play?
- EMA’s vision
- Role of the 4 experts
- Future agile working between industry, regulators and vendors
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Laurent Desqueper - Director Regulatory Affairs in Regional Regulatory Operations EMEA, Merck Sharp & Dohme (MSD)
- Anne Bourrelly - Regulatory Innovation & Sustainment Leader, Roche
- Evolution and trends in regulatory information management
- Introducing the augmented regulatory worker of the future
- Practical examples of augmentation in regulatory information management
- Organisational impact and key considerations to prepare for
- Jens-Olaf Vanggaard - Senior Director, Global Safety, Regulatory and Quality Solutions, IQVIA
- Darius-Jean Namdjou - Head of Regulatory Affairs & Pharmacovigilance, Immunic Therapeutics
- Objectives of the reform
- Introduction of a 4-part package
- Introduction of objectives
- Current challenges and proposed measures
- Key measures
- Next steps and latest update
- Kaili Semm - Policy Officer, European Commission
- Izabela Taborska - Legal and Policy Officer, European Commission
- Understanding the impact of legislation in developing day-to-day workplace processes
- Biggest regulatory updates to be aware of for 2024
- Best practices to stay on top of updates
- Filtering updates into regulatory operational processes
- Filip Cvetanovski - Regulatory Affairs, ALKALOID AD Skopje
- Increasing legislative and regulatory policy activities to regulate data and the use of digital technologies
- Need for active engagement with policy makers to explain the importance of a policy and regulatory landscape that is (1) data and technology interdependent and (2) drives health innovation and creates value for patients and healthcare systems
- Vada A Perkins - Executive Director, Regulatory Policy & Innovation, Bayer
- Alan Chalmers - Director, Pharma International
- Current reliance pathways accepted in China, Japan & Australia
- Alignment between pathways here and in the rest of the world
- Effectiveness of the pathways
- Future planning for further harmonisation
- Stefano Accorsi - Head of Global Regulatory Intelligence and Policy, Chiesi Farmaceutici
- Reliance efforts in ASEAN and South Korea
- Current pathways
- Benefits vs challenges
- Impact for industry
- Expediting drug acceptance
- Streamlining workload
- Céline Bourguignon - Head, Greater China and Intercontinental & Emerging Markets Regulatory Policy, GSK
- A reflection on the project to date
- Impact on patient safety and improved healthcare
- Post-November 2023 – what happens next?
- Christian Hay - Sr Advisor Healthcare, GS1 Global Office
- Frits Stulp - Executive Board Member (Chair), CTADHL
- Current work of CTADHL
- 2023 achievements
- Focuses for 2024
- Current uptake of IDMP in the US
- Impact of cross-Atlantic alignment for industry
- Frits Stulp - Executive Board Member (Chair), CTADHL
- Christian Hay - Sr Advisor Healthcare, GS1 Global Office
- Current priorities of the working group
- Impending updates
- Impact on module 3
- Impact on industry
- How will operations and systems involved change?
- Best practices for coping with transformation
- Laurent Lefebvre - Regulatory CMC Director, Novartis Pharma AG
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Implementation of GSRS software in Europe: EU-SRS
- How G-SRS and EU-SRS benefit from transatlantic alignment
- Lessons learned from the implementation of EU-SRS
- Current status of EU-SRS roll-out
- Users and use cases
- Working with stakeholders
- Next steps in GSRS software development
- Marcel Hoefnagel - Assessor, Biopharmaceuticals, College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)
- Annet Rozema - Project Manager EU-SRS, College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)
- Should regulatory IDMP data be managed separately from the RIM?
- Navigating through controlled vocabularies and mappings
- Challenges in managing a common regulatory dataset for xEVMPD and IDMP
- Meet IDMP compliance with minimum effort: dream or reality ?
- Pierre Stanislawski - Product Director, Ennov
- Vanni Carapetian - Regulatory Data Capability Lead, Genentech
- Key differences between Clinical Trial Directive (CTD) and the Clinical Trial Regulation (CTR)
- The development lifecycle
- How the CTR went from policy driven initiative to operational implementation
- Current feedback on the CTR
- Benefits vs problems
- Lessons to implement moving forward
- Darius-Jean Namdjou - Head of Regulatory Affairs & Pharmacovigilance, Immunic Therapeutics
- Regulatory intelligence being a strategic partner how better can be empowered to assist in Regulatory strategy
- Managing Regulatory intelligence in the global context, Key trends -Focus EU
- Use cases and Case studies examples for better understanding
- Pooja Thakur - Regulatory Intelligence and Reporting Head, Advanz Pharma
In this talk, we will discuss how creation of critical content can be accelerated using (semi-)automated content creation and novel forms of collaborative authoring and review.
The possibility of content automatically being produced using Large Language Models (LLMs) will have a disrupting effect on document-centric processes in pharma. While the human author will ‘stay in the loop’, the role of subject-matter experts will shift from creation to collaborative review and approval.
The rise of LLMs coincides with other developments in document creation and information submissions, such as data-standards to replace documents, the adoption of componentized and structured content-authoring, and the increased demand for compliance and traceability.
The era of authors using a word processor as the centerpiece of documentation processes gives way to a landscape in which humans and machines interact to turn data into readable information in an array of formats. In this talk, Jan Benedictus of Fonto will share his experiences with an integrated approach for data, machine generated content and human authoring. Experiences that come from projects in the pharmaceutical industry and other regulated industries.
- Jan Benedictus - Founder & Managing Director, Fonto
- Darius-Jean Namdjou - Head of Regulatory Affairs & Pharmacovigilance, Immunic Therapeutics
- Where do pharmaceuticals and in vitro diagnostics (IVDs) align with companion diagnostics?
- What are the current regulations for CDx?
- Defining and documenting intended purpose
- Which requirements to follow
- Route to market
- Interacting with EMA, Notified Bodies and Industry
- Lessons to be implemented from both pharma and IVD approval processes
- Jörg Engelbergs - Scientific-Regulatory Expert Targeted & Personalized Biomedicines, Paul-Ehrlich-Institut
- Rolf Thermann - Section Manager IVD and Companion Diagnostics Lead, TUV Rhineland
- Classic post approval change approach vs ICHQ12 post approval change management protocol
- Benefits vs challenges
- Case study
- Abilashan Sithampari - Regulatory Affairs Manager CMC, CSL Behring
- Regional efforts in Middle East and Africa for reliance pathways
- African Medicines Agency
- Experiences of submitting in the region
- Key considerations for submission
- Overcoming hurdles
- Abdul Mateen - Director, Healthcare Consultancy Services, UK
- Nawaf Almutairi, MPharm - Regulatory Affairs Expert, Saudi Food and Drug Authority
- Abebe Alamneh, B Pharm, MSc, - Medicine Registration Expert, Ethiopian Food and Drug Authority (EFDA)
- Recent legislation and updates
- Adoption of ICHQ4 Chinese Pharmacopeia
- Comparison to EU and FDA Pharmacopeia
- Upcoming regulations to expect
- Ching Li - Manager, Corporate Regulatory Affairs, Biotest Pharma GmbH, Germany
- Maria Antonieta Roman - Head Emerging Markets Regulatory Policy, Novartis
- Current reliance pathways
- Variations by drug type – rare disease, innovative drugs
- Impact of external factors on pathways
- Technology
- Covid-19
- Plans for the future
- Maria de la Luz Lara Méndez - Director General, Udelá
- Susan Koepke - Regulatory Affairs Head, Latin America, EMD Serono, Inc
- Diego Alejandro Gutiérrez Triana - Regional Regulatory Director - Colombia, Udela
- Susan Koepke - Regulatory Affairs Head, Latin America, EMD Serono, Inc
- Ana Padua - Associate Director - Global Regulatory Affairs CMC Regulatory Intelligence, Merck Group
- Motivation: Why we need an ontology for IDMP?
- Use Cases: What can I do with the IDMP Ontology?
- Usage: How are pharma companies implementing IDMP-O?
- Governance: How we build the ontology?
- Collaboration: How to participate?
- Heiner Oberkampf - CEO, Accurids
- Melih Tuzunoglu - IDMP-Ontology Project Lead, Pistoia Alliance
- Cedric Berger - Head of Knowledge Extraction and Integration, Roche
- Current regional implementation status
- Adhering to global nuances with adoption
- Future of IDMP implementation
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Patrick Middag - IRISS IDMP Topic Group Lead, Deloitte
- Isabel Chicharo - Head of Regulatory Data Management Service, EMA
- Anne Bourrelly - Regulatory Innovation & Sustainment Leader, Roche
- Laurent Desqueper - Director Regulatory Affairs in Regional Regulatory Operations EMEA, Merck Sharp & Dohme (MSD)
- Frits Stulp - Executive Board Member (Chair), CTADHL
How life sciences companies can use artificial intelligence tools to efficiently consume and assess the impact of global regulatory changes
Life sciences business operations are heavily influenced by regulations. Staying current with the latest regulatory updates is a massive effort that involves researching, collecting, analyzing, and operationalizing the trove of announcements and guidance documents published by national and international health authorities. There's a significant cost and time commitment associated with regulatory monitoring whether it's handled internally or offloaded to external service providers.
Artificial intelligence (AI) tools offer a more efficient, and perhaps a more confident path, to ensuring products remain compliant with global regulations. In this presentation, we'll explore how life sciences Regulatory Affairs and Operations teams can implement AI tools to scan, classify, analyze, and summarize regulatory updates using available sources. We'll also discuss how AI can surface contextual regulatory guidance if, and when, needed for a user's daily work.
Learning Objectives:
- Gain a high-level understanding of how life sciences companies can implement AI tools to monitor and operationalize global regulatory changes.
- Learn about the delicate balance between automated AI analysis of health authority regulations and the role experts play in confirming / improving accuracy of results
- Review specific examples of how AI can be used to monitor and quickly summarize new regulations
- Robin Schilling - Associate Director, Regulatory Product Management, ArisGlobal
- Evolving teams fit for the future
- Enhancing alignment between policy development and operational staff
- Key skills to champion in future workforces
- How will the digitalization of the industry effect policy development?
- Impact this will then have on regulatory operations professionals and their teams
- Sergejs Akuličs - Deputy Director, State Agency of Medicines of the Republic of Latvia
- Darius-Jean Namdjou - Head of Regulatory Affairs & Pharmacovigilance, Immunic Therapeutics
- Sophie Dagens - Regulatory Policy Officer, Medicines for Europe
- Importance of reliance pathways for the next 5 years
- Link to good regulatory practice
- Lessons learned from the last 5 years
- Covid
- Technology
- Current plans for further global harmonisation
- Stefano Accorsi - Head of Global Regulatory Intelligence and Policy, Chiesi Farmaceutici
- Céline Bourguignon - Head, Greater China and Intercontinental & Emerging Markets Regulatory Policy, GSK
- Maria Antonieta Roman - Head Emerging Markets Regulatory Policy, Novartis
- Faraat Ali - Manager, Department of Inspection and Enforcement, Laboratory Services, Botswana Medicines Regulatory Authority (BOMRA)