Sunday, 28 May 2017

Download Complementary  medicines applications extension - press statement

The aims of the PV policy handbook are to firstly provide a framework for a national

pharmacovigilance system in Zimbabwe. Secondly, to define the pharmacovigilance activities undertaken by the Pharmacovigilance centre and stakeholders. Thirdly to delineate the trends and signals of adverse events with medicines used in the country and help policy makers utilize evidence-based practice in patient safety and therapeutics.

Click  to download Zimbabwe National Pharmacovigilance Policy Handbook

The Medicines Control Authority of Zimbabwe (MCAZ) as a responsible corporate citizen runs a Scholarship Fund as part of its corporate social responsibility programmes.
 

Click here to download the Scholarship Programme Publicity

The MCAZ offers training services for new and seasoned regulators from national medicines regulatory authorities (NMRAs), regulatory affairs personnel from the pharmaceutical industry, and people from academia.

The course is designed as a six-week competency based training program. The training has three parts (a) readings, and assignments for 3 weeks, (b) intensive one-week training on the key principles of interchangeability, application of concepts of ethics, clinical conduct, study designs, pharmacokinetics, statistics, bioanalysis and method validation, in bioequivalence (BE), and (c) demonstration of competence through review of actual bioequivalence data submitted for applications for registration of medicines. The second part is only applicable to participants working for medicines regulatory authorities or equivalent, or those in academia.

Pre-requisites

The participants should have a bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, medicine, veterinary or the life sciences with at least two years working experience in a relevant field such as in medicines regulation, pharmaceutical manufacturing industry, research and/or academia.

Participants should have requisite knowledge of basic principles of biopharmaceutics, pharmacokinetics, therapeutics, statistics, bio analysis and method validation.

Course Format

The course format and delivery has been carefully selected to ensure that completion for the course simulates the real life of a regulatory officer responsible for performing the product assessments or regulatory officer at pharmaceutical or clinical research organization responsible for quality assurance and compliance, regulatory filing of study results. The goal is to ensure successful conduct of bioequivalence studies meeting regulatory requirements and / or appropriate review of the bioequivalence submissions for registrations of medicines. As such, two key principles are applied; competence based approach (rather than knowledge and memory based approach) and participant centered learning.

Course Objectives:

The objective of this course is to train and equip participants with the requisite knowledge and skills relating to demonstration of interchangeability to enable them to evaluate data to demonstrate interchangeability through bioequivalence for registration of medicines.

Learning Outcomes

By the end of this course, participants should be able to:

  1. Articulate the scientific & regulatory basis and assumptions for demonstration of interchangeability,
  2. Demonstrate knowledge, understanding and application of key principles of ethics, good clinical practice (GCP), biopharmaceutics, pharmacokinetics, statistics and bioanalysis in bioequivalence,
  3. Analyse and draw conclusions on available data to demonstrate bioequivalence based on application of relevant requirements in applicable regulatory guidelines
  4. Review and write a scientific assessment report on data submitted in the application for registration of a medicine in accordance with applicable regulatory guidelines

Course content

The course content is divided into three components as follows:

A. Foundation:

  1. Regulatory requirements for registration of medicines
  2. Demonstration of interchangeability

B. Scientific Principles

  1. Good Clinical Practice (GCP)
  2. Biopharmaceutics
  3. Pharmacokinetics
  4. Statistical methods in bioequivalence
  5. Bioanalytical methods
  6. Bio analytical methods validation
  7. Comparative dissolution

C. Application

  1. Study designs
  2. Study conduct
  3. Data analysis

Target Group

While the primary focus is on regulators, the course is relevant to professionals in the pharmaceutical industry and contract research organisation (CRO) responsible for design, analysis, filing and compliance with regulatory requirements.

The RCORE will provide partial funding to cover the course fee for eligible participants from regulatory agencies.

Application Process

Interested candidates are required to submit a completed application form (available on the website www.mcaz.co.zw), and support letter from the employer (including confirmation of the funding) to the Director - General, MCAZ by email at This email address is being protected from spambots. You need JavaScript enabled to view it. ; This email address is being protected from spambots. You need JavaScript enabled to view it..

Click to download Bioavailability/Bioequivalence (BA/BE) Course Application Form

Click to download MCAZ RCORE TRAINING BROCHURE

 

 

These guidelines are under review and comments are welcome. 


Download Draft Guidelines for Advertising and Promotion of Medicines

 

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