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Zenosis Module

Click to select your preferred Zenosis module CT01: How to Obtain Approval to Conduct Clinical Trials in the EU CT01: How to Obtain Approval to Conduct Clinical Trials in the EU CT03: An Introduction to ICH Good Clinical Practice (ICHJ-GCP) CT04: An Introduction to Clinical Trial Preparation and Design CT05: An Introduction to Clinical Trials in India CT06: Clinical Trial Monitoring: Site Evaluation and Setup CT07: Introduction to Clinical Trials and Drug Development CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure CT09: Preparing for a GCP Audit or Inspection CT10: The IND: How to Gain Approval for Clinical Trials in the USA CT10: The IND: How to Gain Approval for Clinical Trials in the USA ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products GXP01: An Introduction to Good Manufacturing Practice (GMP) for Drug Products PV03: An Introduction to Drug Safety and Pharmacovigilance SC01: Pharmacokinetics and Pharmacodynamics in Drug Registration SUB01: Orphan Drug Applications in the EU and USA SUB02: The European Centralised Procedure (CP) SUB03: The Mutual Recognition Procedure (MRP) SUB04: Preparing Submissions in the Common Technical Document (CTD) Format SUB05: Electronic Common Technical Document (eCTD) SUB06: Variations to Marketing Authorisations in Europe SUB07: Registration of Monoclonal Antibodies SUB08: The ANDA: Requirements for Obtaining Approval for a Generic Product in the USA SUB09: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA SUB11: The Decentralised Procedure (DCP)

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