* Observation of a Technical Advisory Committee meeting on Clinical Trials

* Evaluation/review of trial reports (SAE reports, quarterly progress reports

etc. received from trial sites, safety reports and final clinical study reports)
CONTACT US
* Observation of a Good Clinical Practice inspection at a trial site.

ADMISSION REQUIREMENTS
Postal Address
Applicants must be interested in product development and clinical trials.
Food and Drugs Authority
OR P. O. BOX CT 2783
Cantonments
Applicants must have been working with a National Regulatory Agency
(NRA) for clinical trials for at least one year.
Accra- Ghana

(Applicants with previous experience in clinical trials will have an added Telephone
advantage)

(+233-302) 233200/235100
HOW TO APPLY

Applicants must complete the application form available at http:// Mobile

www.fdaghana.gov.gh/images/stories/pdfs/Training/RCORE-%
20application%20form.pdf +233 244 310 297
or pick up a form from the FDA Head Office, Accra.
Fax
The application should be supported with the following (with translations
where applicable): (+233-302) 229794/225502
* a copy of participants current curriculum vitae (CV)
E-Mail RCORE CLINICAL TRIAL
* an introductory letter from the Applicant’s institution / agency.
REGULATORY
* a personal statement which should include amongst others the following fda@fdaghana.gov.gh FELLOWSHIP PROGRAMME
information: or drug.safety@fdaghana.gov.gh
* applicant’s motivation to undertake this program (additional
information to support this is recommended)
Physical Address/Location
* applicant’s skills and experience that is relevant to this program

* statement on how this program benefit applicant’s future career plans No. 17 Indian Ocean Street,
Nelson Mandela Avenue
FEES (covers tuition, course materials, in-country transportation,
accommodation and meals during the training)
South Legon
Commercial Area
 Foreign applicants: USD 3,500.00 (excludes airfare and airport pick-up/ Shiashie-Accra
drop-off)

 Ghanaian applicants: USD 1,500.00 or its cedi equivalent

(excludes accommodation)
5 6
 I. Clinical Trials Authorization II. GCP Inspections
ABOUT US
Clinical Trials in Practice
Trial Designs
This module investigates the key steps in the logistical and implementation of
The Food and Drugs Authority (FDA) is an Agency of the Ministry of Health, This module introduces participants to increasing variety of designs used in clinical
clinical trials. It clarifies and operationalizes the primary and secondary
Ghana and was established in August 1997. It is the National Regulatory trials, and this will enable participants to understand their fundamental character-
objectives of clinical trials and implications of design choices for implementa-
Authority mandated by the Public Health Act 2012, (Act 851) to regulate istics and appropriate use in the testing of therapies and other interventions.
tion of a trial. The module will also examine the governance , data collection
food, drugs (including biologicals, blood and blood products), food and recruitment methods. Quality assurance and control, data processing and
supplements, herbal and homeopathic medicines, veterinary medicines, Basic Statistics for Clinical Trials
management issues will be explored as well.
cosmetics, medical devices, household chemical substances, tobacco and The aim of this unit is to introduce students to basic statistical methods relevant in

tobacco products, and clinical trials in Ghana. clinical trials. Students will learn how to select and apply statistical methods to
Regulatory Issues, Good Clinical & Laboratory Practice
understand data from clinical trials and to present, interpret and discuss the anal-
The module seeks to develop participants understanding of the main features
The FDA, Ghana was designated by the New Partnership for African yses clearly and concisely.
relating to regulatory legislation and associated approvals and permissions
Development (NEPAD) and the African Regulatory Harmonization (AMRH)
required to conduct high quality clinical trials. Key issues relating to the
as a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials and
Drug Registration in May 2014.
legislation of Good Clinical Practice (GCP), understanding GCP, implementing III. Adverse Events and Safety Monitoring
GCP, including risk assessment and trial monitoring will be discussed. Good
(Pharmacovigilance)
As an RCORE, the FDA in collaboration with the School of Public Health, Laboratory Practice (GLP) in trial settings, Quality control and assurance

University of Ghana, seeks to build capacity in Clinical Trials within the sub- systems shall also be explored. The focus will be on trials of drug products but
Pharmacoepidemiology and Pharmacovigilance
region and improve access to medicine though harmonization of regulatory trials in variety of other areas and in different locations will be taught.
The module provides the history and need for pharmacovigilance. It discusses
requirements. This will ensure that quality, safe and efficacious medicines
principles of pharmacovigilance, pharmacovigilance reporting systems, tools for
are available to African citizens. Ethics of Clinical Research in developing countries
management of reports, global initiatives in pharmacovigilance, regulatory
The course aims to discuss the critical ethical issues related to conducting
pharmacovigilance, signal detection in pharmacovigilance, post market approval
OBJECTIVES OF PROGRAM clinical trials in the developing world. The course will cover a historical
and Phase IV safety Monitoring, safety and data analysis trends, causality assess-
overview of research ethics in the developing world, medical and human
* Build capacity and enhance skills of regulators in the area of effective ment principles & analysis.
ethics, risk-benefit assessments, vulnerable populations as research subjects,
clinical trial regulation through hands-on training and exchange programs informed consent process and documentation, privacy and confidentiality of
to help improve their output. Reporting and Reviewing Clinical Trials
research subjects and data, responsible conduct of scientific research, the role
This course is to enable the students to describe how trials are reported using best
and functions of Institutional Review Boards, Data and Safety Monitoring
* Increase regulatory workforce to facilitate quality review of clinical trials practice and how systematic reviews are carried out and reported.
Boards, international research and the Declaration of Helsinki
conducted in Africa.

* Provide a platform for regulators and researchers to continually share Protocol Development

ideas, knowledge and experiences over the years in the aim of improving The aim of this module is to be able to learn to develop the trial protocol and IV. REGULATORY ATTACHMENT
their activities the steps to be taken for preparing the protocol for a trial: This entails how to
Fellow trainees together with the FDA trainers will follow a 15-day practical
develop the data collection forms, understand the required logistical and
regulatory attachment for the trainees at the Food and Drugs Authority’s Clinical
Build capacity and enhance skills of researchers in the area of conduct of budgetary issues in the preparation of the protocol, and procedures different
Trials Department to acquire hands-on training skills on the theoretical aspects of
clinical trials through hands-on training to help improve their output. funding bodies use to award grants.
the course.

30-DAY INTENSIVE FELLOWSHIP COURSE

Hands-on activities will be in the following areas:

COURSE CONTENT
* Evaluation of Clinical Trial Applications submitted for regulatory approval which

To achieve the above objectives, the FDA has designed an intensive will include protocol and Investigator’s Brochure review/assessment, etc.

fellowship course covering the following areas;

2 3 4