PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Saturday, 24 October 2020

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QUALITY MANAGEMENT SYSTEMS AND LEADERSHIP

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover leadership and quality management systems in a regulatory environment. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


MOLECULAR BASIS OF MANUFACTURING & QUALITY BY DESIGN

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover the molecular basis of manufacturing and Quality by Design principles. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


PROCESS VALIDATION

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover process validation in the manufacture of pharmaceuticals. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


 

ANALYTICAL METHODS VALIDATION

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover analytical method validation and include a visit to the MCAZ WHO prequalified laboratory. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


 

GMP CONSIDERATIONS FOR ASSESSORS

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover GMP considerations for assessors and include a visit to a leading pharmaceutical manufacturing plant. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


 

BIOANALYTICAL METHODS & VALIDATION  

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover bioanalytical methods and validation in bioequivalence. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


 

STATISTICAL METHODS IN BIOEQUIVALENCE  

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover statistical methods in bioequivalence. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


 

ADVANCED BIOEQUIVALENCE STUDY DESIGNS

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover advanced bioequivalence study designs. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


 

ASSESSMENT OF QUALITY FOR BIOSIMILARS

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover assessment of the quality section of biosimilars. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500
 

 


 

ADVANCED DRUG DELIVERY SYSTEMS

This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover advanced drug delivery systems. The course is an opportunity to meet seasoned regulators and experts in the field. A certificate of completion will be awarded at the end of the training.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 1500