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EU Clinical Trials Regulation
16 June, 2022
Digital Conference12:00PM CEST // 11:00AM BST // 6:00AM EST
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EU Clinical Trials Regulation - CET (Central European Time, GMT+01:00)

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EU Clinical Trials Regulation - CET (Central European Time, GMT+01:00)
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Showing 1 of 1 Streams
12:10pm - 12:15pm
Welcoming Remarks
12:15pm - 12:45pm
The CT Portal & Database – What does this look like and what does it mean?
  • Laura Brown - Director, Laura Brown Training
12:45pm - 1:15pm
EU Regulators Perspective
  • Gunilla Andrew- Nielsen - Head of Department of Clinical Trials and Special Permissions, Medical Products Agency, Sweden
1:15pm - 1:45pm
EU Regulators Perspective
  • María Antonia Serrano Castro - Head of Clinical Trials Division, Department of Human Medicinal Products, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain
1:45pm - 2:15pm
EU Regulators Perspective: Practical Aspects of the EU CTR and CTIS
  • Monique Al - Team Coordinator National Clinical Trial Office, Central Committee on Research Involving Human Subjects (CCMO), Netherlands
2:15pm - 2:45pm
Coffee Break & Networking
2:45pm - 3:15pm
Impact and Industry Perspective for Clinical Trial Regulation
  • Tom Denorme - Director, Regional Submissions Lead Head, GCTO EMEA, MSD, Belgium
3:15pm - 3:45pm
Handling requests for information & RFI’s – Lessons Learnt
  • Scott Feiner - Senior Manager, Clinical Records Management, Strategic Clinical Operations, AbbVie, United States
3:45pm - 4:15pm
Ask the Experts – Speaker Q&A Session
  • Tom Denorme - Director, Regional Submissions Lead Head, GCTO EMEA, MSD, Belgium
  • Monique Al - Team Coordinator National Clinical Trial Office, Central Committee on Research Involving Human Subjects (CCMO), Netherlands
  • Gunilla Andrew- Nielsen - Head of Department of Clinical Trials and Special Permissions, Medical Products Agency, Sweden
  • Laura Brown - Director, Laura Brown Training
  • Scott Feiner - Senior Manager, Clinical Records Management, Strategic Clinical Operations, AbbVie, United States
  • María Antonia Serrano Castro - Head of Clinical Trials Division, Department of Human Medicinal Products, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain
4:15pm - 4:45pm
End of Day & Networking on the Platform
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