Regulatory Affairs
Online Training Id: ITPRA
Geographical Region: International
Level: Basic
This module is an introduction to International regulatory requirements for Developing , Manufacturing and distributing medicines for Human use and provides a basis for Pharmaceutical Regulatory Affairs knowledge essential for all staff working in Health Care and the Pharmaceutical Industry
Learning Objectives:
Delegates will gain a clear understanding of preparing a Product registration dossier and in particular will learn ;
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Principals for Drug product Registration and role of regulatory authority in drug approval.
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Review of the controls achieved from compliance in GxP practices.
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Preparation of Drug regulatory submissions in Common Technical Document (CTD)
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Evaluating the risks to quality associated with deviations in registered specification for Drug substance and Drug Productand for evaluating risk to Quality
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Principals of evaluation of Drug safety and pharmacoVigilance
Who Should Enroll:
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Staff newly appointed to positions in following positions.
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Regulatory Affairs.
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Manufacturing, pharmaceutical manufacturing, engineering, analytical development, packaging development, QC and QA staff.
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Clinical trials staff, medical and scientific affairs, medical affairs, and project management.
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Pharmaceutical Development & Technology transfer senior managers.
CPD Credit hours: 150 mins
Author:
John DR Jolley - FR Pharm S, FCQI CQP is a co-founder of Pharma Consult Global, a Pharmaceutical Consultancy providing technical consultancy and training European countries, Middle East, South Africa and the USA and involving International Pharmaceutical Experts from around the world. He is a pharmacist who has held positions in Clinical Research, Product Registration, Pharmaceutical Manufacturing, Quality Assurance, and General Management. He was Technical Director for Boehringer Ingelheim UK for 15 years before working in Technical consultancy. He is a practicing Qualified Person (QP) for pharmaceutical manufacturing, Distribution and Clinical Research organizations, and is an Industry representative on the EMA advisory committees for GMP/GCP. John has a degree in Pharmacy and has been awarded fellowships with the Royal Pharmaceutical Society and the Chartered Quality Institute.
John Dr Jolley FR PHARM S, FCQI CQP