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The Regulatory Dossier Evaluation Training

Professor

Dr Eric Karikari-Boateng

Category:

Regulatory Sciences

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Course Description


Course Objectives for The Regulatory Dossier Evaluation Training


Asmara Eritrea 


14th to 21st April 2019


Course Objectives


- The main objective of the training programme is to ensure that, Assessors(Reviewers) of the Eritrea Medicines Regulatory Authority are competent and capable of reviewing Marketing Authorisation Files (for Generic Products)submitted by Applicants  in line with international best Regulatory Standards and Practice (ICH M4Q ,M4S aND M4E)




- The Reviewers shall be trained to make  use of sound scientific judgements taking into account the following factors when reviewing dossiers

Public Health Benefits (Benefit to Risk Ratio)

Critical Thinking based on valid and sound Scientific principles

Scientific uncertainty

Risk Assessment

Risk management

Expected outcomes 


At the end of the course the expected outcomes will be

1) Reviewers from the Regulatory Agency will be able  to distinguish a Good and acceptable Drug Master File(DMF) of Active Pharmaceutical Ingredient(APIs) from substandard DMFs

2) Understand the concept of Pharmaceutical Development, Process Development and Process Validation in the manufacture of Drug Products (FPP) and apply them in the review process

3) Understand the principles of Analytical method Validation for Assay,Dissolution ,and Related substances and impurities and apply them when reviewing Analytical control procedures for non compendial Finished Pharmaceutical products (FPPs)

4) Understanding Data integrity issues  when reviewing Analytical method Validation reports and readouts

5) Reviewers shall be able to evaluate Stability data for both Finished Pharmaceutical Products (FPP) in accordance with ICH Q1 requirements.

Please  kindly note that real dossiers that have been submitted to the Agency will be used in the case studies.

About the Faculty

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Dr Eric Karikari-Boateng

Head of Laboratory Service Department

Dr Eric Karikari-Boateng a Pharmacist holds an Msc (Pharmaceutical Science (Pharmacology and Toxicology) from Zaporozhye State Medical University, Ukraine. Upon graduation in 1995, he joined the newly formed Food and Drugs Administration in Ghana in 1997. He is currently the Head of Laboratory Service Department and a Senior Reviewer of CMC sections of Marketing Authorization Files for New Biological Applications which includes well characterized Biologics (e.g. Mabs, fusion proteins) vaccines, other recombinant proteins (Insulin, and its analogues and epoetins) and Biosimilars. His main interests are characterization of protein using high throughput orthogonal method, especially Glycan Analysis. Purification of proteins and Bioassays. Eric is a certified GMP Pharmaceutical Professional of the American Society of Quality ASQ and facilitator at the United States Pharmacopoeia (USP) Ghana and he is responsible from training personnel of National Regulatory Authorities (NRAs) in Africa in the Review of MAA for Biologics and small molecules.

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