Seerpharma.com.au :: Pharmaceutical Consulting & Training :: Validation, GMP & Compliance UK | Singapore

   

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Click on one of the module series below to see more information about our regulatory and compliance modules.

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SeerPharma has partnered with Intellego to distribute their suite of drug development, registration, and clinical trials.

 

 

Intellego web-based training
 

ESS01 Essentials of EU and US Regulatory Affairs for Human Medicinal Products

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 EU Variations Procedure

SUB07 Registration of Monoclonal Antibodies

SUB08 The ANDA: Requirements for Obtaining FDA Approval for 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)

PV01 An Introduction to Pharmacovigilance (PV)

 

CT01 How to Obtain Approval to Conduct Clinical Trials in the EU

CT03 An Introduction to ICH Good Clinical Practice (ICH-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 Set-up

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

SC01 Pharmacokinetics and Pharmacodynamics in Drug Registration

GXP01 An Introduction to Good Manufacturing Practice (GMP) for Drug Products

 

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