Pharmaceuticals Track

Type here to filter the list

Monday, May 6th
08:30 – 16:00 CEST
Pre-Conference Workshop: Global Regulatory CMC Approaches for Biologicals: From Strategy to Execution
Location: A 04
Workshop Leader: Neha Parashar, PMP® and PRINCE2® – Argenx
Presenter: Ankit Geete, RAC, PMP, CDMP, CBIP – BioNTech SE
Pharmaceuticals
Tuesday, May 7th
08:30 – 09:30 CEST
Development and Registration of Therapeutic Radiopharmaceuticals in the EU – Navigating Opportunities and Challenges
Location: A 05 + A 06
Presenter: Rezaul Karim, PhD, MSc – Starodub BV
Pharmaceuticals
Tuesday, May 7th
08:30 – 09:30 CEST
Patient Access: Regulatory, HTA, and Patient Perspectives on an Orphan Drug – Case Study of Erythropoietic Protoporphyria
Location: B 07 + B 08
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Presenter: Meriem Bouslouk-Marx, PhD, MSc International Health – MBM Future Health, AMNOG Advisory Services
Presenter: Jasmin Barman-Aksözen, PhD – International Porphyria Patient Network (IPPN)
Presenter: Karl-Heinz Huemer – khhconsulting
Panelist: Kristina Larsson, MSc – European Medicines Agency
Pharmaceuticals
Tuesday, May 7th
09:50 – 10:50 CEST
Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions
Location: B 05 + B 06
Moderator: Magda Bujar
Presenter: Cesar Vinces – Accumulus Synergy
Presenter: Frank Dickert – EXTEDO GmbH
Presenter: Rachel Bombara – Certara
Pharmaceuticals
Tuesday, May 7th
09:50 – 10:50 CEST
New EU Pharma Legislation
Location: A 05 + A 06
Presenter: Rebecca Lumsden, PhD – Sanofi
Presenter: Julie Spony, MA – European Patients' Forum
Presenter: Alberto Ganan, PhD – European Medicines Agency
Presenter: Sini Eskola, M.Sci Pharmacy – EFPIA
Presenter: Lilia Luchianov – European Commission
Pharmaceuticals
Tuesday, May 7th
11:30 – 12:30 CEST
Key Trends Impacting HTA and Regulatory Interface
Location: B 07 + B 08
Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
Presenter: Nathalie Largeron, MSc, PharmD – Sanofi
Presenter: Katharine Cresswell, MPH – National Institute for Health and Care Excellence
Panelist: Michael Berntgen, PhD MDRA – European Medicines Agency
Pharmaceuticals
Tuesday, May 7th
13:45 – 14:45 CEST
Meeting EMA and FDA: Formal and Informal Pathways in Search of Alignment
Location: A 05 + A 06
Presenter: Jasmina Savic – Phortas GmbH
Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency
Presenter: Jayne Hunt, PhD – Arriello
Pharmaceuticals
Tuesday, May 7th
13:45 – 14:45 CEST
Unveiling Insights: Navigating the Public Disclosure of Clinical Trials in an Evolving Industry
Location: B 07 + B 08
Presenter: Christopher Bamford, PhD – IQVIA
Presenter: Anaya Rehman, MBBS, MSc – Certara
Presenter: Lene Grejs Petersen, M.Pharm – Danish Medicines Agency
Panelist: Radu Popescu, MD – European Medicines Agency
Pharmaceuticals
Tuesday, May 7th
15:05 – 16:05 CEST
From China to WHO: Strategies and Updates to Accelerate China and WHO Drug Approvals and Master Files
Location: A 03 + A 04
Session Leader/Speaker: Hamish King, RAC, LLB – Cisema
Presenter: April Wang, MA – Accestra Consulting Company
Presenter: Gerhard Neurauter, PhD – EXTEDO GmbH
Pharmaceuticals
Tuesday, May 7th
15:05 – 16:05 CEST
MDR Art. 117 for Combination Products. Are the Challenges Solved Now? State of Play From EMA, NB and Industry
Location: B 05 + B 06
Session Leader/Speaker: Stephan Affolter – Ypsomed AG
Presenter: Christelle Bouygues, PharmD – EMA
Presenter: Christiana Hofmann, PhD – Sandoz
Presenter: Theresa Jeary, BSc (Hons), MSc – BSI Group
Pharmaceuticals
Tuesday, May 7th
16:45 – 17:45 CEST
Importance of New Active Substance Status for Biologics, and CMC Strategies for Development of C&G Therapies
Location: A 05 + A 06
Session Leader/Speaker: Sanjay Jain – Fortrea
Presenter: Marie-pierre PETITJEAN, PharmD – Sanofi
Panelist: Brian Dooley
Pharmaceuticals
Wednesday, May 8th
10:25 – 11:25 CEST
CTA with Devices: State of Play for Non-CE Marked Diagnostic Tests in European Clinical Trials
Location: A 05 + A 06
Presenter: Pieter Bogaert, PhD – Qarad
Presenter: Sven Hoffmann, MSc – Entourage GmbH
Pharmaceuticals
Wednesday, May 8th
11:45 – 12:45 CEST
Patient-Centric Endpoints and Use of Digital Health Technologies
Location: A 03 + A 04
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Presenter: Karl-Heinz Huemer – khhconsulting
Presenter: Anirban Sadhu – Teva Pharmaceuticals
Presenter: Adrienne Lenz, RAC – Hyman, Phelps & McNamara, P.C.
Pharmaceuticals
Wednesday, May 8th
11:45 – 12:45 CEST
Supply Chain/Shortage
Location: A 05 + A 06
Presenter: Rachel Harte – CAI
Presenter: Sarbajit Chakrabarti, MTech, MSc – Parexel International India Safety Services Private Limited
Presenter: Siegfried Schmitt, PhD – Parexel
Presenter: Monica Dias, PhD – EMA
Pharmaceuticals
Wednesday, May 8th
14:00 – 15:00 CEST
Data at the Core: Understanding Your Company's Critical Yet Underutilized Tool
Location: A 03 + A 04
Moderator: Charlie Mortazavi, SANOFI – SANOFI
Presenter: James Cross, PhD – Asher Biotherapeutics, Inc.
Presenter: Deborah Bebbington – Bayer Plc
Presenter: Nathalie Gass, PhD – F. Hoffmann-La Roche Ltd
Pharmaceuticals
Wednesday, May 8th
14:00 – 15:00 CEST
International Regulatory Frameworks to Accelerate Orphan Drug Registrations
Location: A 05 + A 06
Session Leader/Speaker: Merce Caturla Goni, PhD – Alexion Astra Zeneca Rare Diseases
Presenter: Kristina Larsson, MSc – European Medicines Agency
Presenter: Tomasz Grybek, MA – Foundation of Borys the Hero
Pharmaceuticals
Wednesday, May 8th
15:40 – 16:40 CEST
Blood, Sweat, and Tears – Biologics and Their Challenges
Location: A 05 + A 06
Moderator: Siegfried Schmitt, PhD – Parexel
Presenter: Ralf D. Hess, PhD – ENTOURAGE GmbH
Presenter: Yingying Liu, MSc – Pharmaceutcial
Pharmaceuticals
Wednesday, May 8th
15:40 – 16:40 CEST
Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a Case Study
Location: A 03 + A 04
Presenter: Kasia A. Nowok, MSc – UCB
Presenter: Rüdiger Faust, PhD – UCB
Presenter: Nasir Hussain, BPharm, MBA, PhD – Gilead
Pharmaceuticals