Report Adverse Drug Reaction
REGISTERED PRODUCTS
TEST RESULTS
VACANCIES
DATABASE

PHARMACOVIGILANCE (PV) & CLINICAL TRIALS (CT)

OVERVIEW
With increased access to essential medicines comes a greater need to monitor and promote the safety and effectiveness of these medicines, thus the need for the establishment of the Pharmacovigilance & Clinical Trials Department as one of the four (4) technical departments of the Liberia Medicines & Health Products Regulatory Authority (LMHRA). The main role of this Department is to ensure effective surveillance systems throughout the life-cycle of the healthcare product, which is very critical to public health protection. Accordingly, the Department trains health workers, collects reports of adverse drug reaction (ADR), collates and analyses them and provides feedback for regulatory decisions when applicable.  

STRUCTURE OF DEPARTMENT
Currently, the Department of Pharmacovigilance & Clinical Trials has four (4) registered Pharmacists (PharmD) as well as other support staff, including two (2) Physician Assistants. Dr. James D. K. Goteh, one of the Authors of the Pharmacovigilance and Clinical Trials Guidelines, serves as Director of the Department. Dr. Goteh has many years of the experience of work in this field and represented Liberia at many international meetings and conferences. Dr. Nuku B. Williams is the Deputy Director of the Department. While Dr. Margaret serves as head of the Pharmacovigilance Unit, Mr. Theophilus T. Fayiah (PA) and Mr. Francis A.B. Jumu, III (PA) serve as support staff to the department.
  • Dr. James D. K. Goteh
  • Director of Pharmacovigilance & Clinical Trials

Dr. James D. K. Goteh, a Registered Pharmacist, currently serves as Director of the Pharmacovigilance & Clinical Trials Department for the Liberia Medicines and Health Products Regulatory Authority.

Dr. Goteh has many years of the experience of work in this field and represented Liberia at many international meetings and conferences. He is one of the Authors of the Pharmacovigilance and Clinical Trial Guidelines respectively. Dr. Goteh is also a Co-authors for the publication titled “ Prevalence of Plasmodium falciparum infection among pregnant women at first antenatal visit in post-Ebola Monrovia, Liberia”

 He is a graduate of the Cutington University with a Bachelor of Science Degree in Biology (B.Sc.) and the School of Pharmacy, University of Liberia with a Bachelor of Pharmacy Degree (B-Pharm.) in 2003 and 2011 respectively. Dr. Goteh also graduated from the University of Benin, Nigeria with a Doctor of Pharmacy Degree (PharmD).

In addition to his academic and work-related achievements, Pharm. Dr. Goteh has participated in several pharmaceutical related international workshops/trainings (local and international). From these workshops and trainings, he has obtained certificates in the following areas: Bioequivalent/Bioavailability, Pharmacovigilance courses (Modules I & II), Clinical Trials, Financial and Project Management, etc.

Dr. Goteh is a member and had served as Secretary General and Vice President of the Pharmaceutical Association of Liberia (PAL), respectively. He has also served as a member of the West African Health Organization (WAHO) Expert Working Group on Clinical Trials, Pharmacovigilance and Post Market Surveillance for the West African Medicines Regulation Harmonization Project as well as a member of the International Society of Pharmacovigilance (ISoP).

Dr. Goteh has worked as a Classroom Teacher of the Dolokelen Gboveh High School and William Booth Junior & Senior High School of the Salvation Army School System in Liberia respectively.

As a Pharmacist, he has also worked as Medicine Dossiers Evaluator, Clinical Trial Protocols Reviewer, Trainer of healthcare Workers, Pharmacovigilance & Clinical Research of the Liberia Medicines and Health Products Regulatory Authority (LMHRA) since 2011.

Dr. Nuku B. Williams is a registered Liberian Pharmacist currently serving as the Deputy Director for Pharmacovigilance and Clinical Trial for the Authority. 

Dr. Nuku B. Williams obtained Doctor of Pharmacy (PharmD) from the University of Benin (UNIBEN), Nigeria; Bachelor of Pharmacy (BPharm), School of Pharmacy, University of Liberia; Bachelor of Science (B.Sc.) in Biology and Chemistry from TJR Faulkner College of Science and Technology of the University of Liberia and a graduate from the Haywood Mission High School.

Dr. Nuku B. Williams have worked for the Authority for the past eight (8) years in various positions: prior to serving as Deputy Director for PV, he served as Manager for Premises Licensing from 2012 to 2015 and Deputy Director for the Inspectorate and Post Market Surveillance from 2015 to 2019.

Dr. Nuku B. Williams received several trainings Professional Regulator with many local and international institutions, including hands-on GMP Training on entrance Pharmaceutical Company in Ghana, as well as received certification in the following:

  • Introductory Discussion ICH, GCP AND GLP, Monrovia, Liberia
  • Good Manufacturing Practice Training (GMP), USP/USAID Monrovia, Liberia
  • Good Manufacturing Practice Training (GMP) CePAT, Accra Ghana
  • Wastes Management Training for the Maintenance of the Modern Incinerator, ICRC, Monrovia, Liberia
  • Registration Software Inspection Module Training Promoting the Quality of Medicines United State Pharmacopeia, Liberia
  • Training of Trainers Workshop for Accredited Medicine Stores for Liberia Sustainable Drug Seller Initiative (SDSI), Monrovia, Liberia
  • Training of Trainers for Ebola Response Pharmacy Board of Liberia (PBL), Liberia Medicine and Health Products Regulatory Authority (LMHRA), Pharmaceutical Association of Liberia (PAL), In Collaboration with Mentor Initiative, Monrovia, Liberia
Pharmacovigilance Unit

As enshrined in Part III, Count 5 of the LMHRA Act, the Authority is charged with the responsibility to conduct or facilitate necessary research and development, promote Pharmacovigilance, and disseminate timely drug information.

The Pharmacovigilance (PV) Unit is established to monitor the safety of all medicines and health products in Liberia and to share these reports with the international body. In 2013, the LMHRA met the basic requirements of the World Health Organization (WHO) International Drug Monitoring Program thereby becoming the 112th Official Member and at the same time gained the status of a National Pharmacovigilance Center (NPC).

The guideline for the National Pharmacovigilance System in Liberia has been developed to complement and support the efforts of educating all healthcare workers on this important concept and enhance their efforts in ensuring that safe, efficacious and quality medicines are made available to the entire Liberian populace.

Activities

  • Roll out Adverse Drug Reaction (ADR) forms to various health facilities and conduct training for health care workers in adverse drug reporting.

  • Coordinate with other health programs including the Expanded Program for Immunization (EPI), National AIDS Control Program (NACP) and other vertical programs to collect ADR reports

 

  • Report to the World Health Organization (WHO) International Drug Monitoring Program

CLINICAL TRIAL Unit
CT Validation & CTA Assessment Forum
As enshrined in the Act establishing the LMHRA all clinical studies involving humans and animals shall be authorized by LMHRA in accordance with Part V, Section 5 counts 1 & 2 as stated below.
  • No person/organization shall conduct clinical studies in humans or animals of medicines or health products without the authorization of the Authority.
  • The conditions for authorization of such clinical studies shall be stipulated in regulations promulgated by the Authority that shall provide for the issuance, renewal, suspension, cancellation and revocation of such authorizations.
Considering the aforementioned, the Clinical Trials Unit at the LMHRA is established with the responsibility to:
  • Receive and assess all Clinical Trial applications (CTA) submitted at the LMHRA.
  • Conduct Good Clinical Practice (GCP) inspection at trial sites to ensure compliance in line with the LMHRA regulatory requirements and International best practices
  • Review all reports from CT sites and advise management on appropriate regulatory actions
  • Investigate the conduct of Clinical Trials
  • Suspend or stop Clinical Trials (depending on the magnitude of the offense)
Specifically, the Clinical Trials Unit performs the following activities:
  • Receives and processes all clinical trials applications (CTA) for review
  • Conducts GCP inspection at trials sites
  • Conducts GCP training for inspectors and study team
  • Serves as secretariat for the Scientific Advisory Committee on clinical trials
  • Reviews importation permits for investigational products that are required for the conduct of clinical trials
  • Conducts pre- submission meetings to discuss issues related to application processes
  • Reviews all reports (safety reports, quarterly reports, Serious Adverse Events-SAE reports and final or close-out reports from clinical trials conduct.

    The Clinical Trials Unit is headed by Dr. Juwe D. Kercula who is one of the Authors of the LMHRA first clinical trials guidelines. Dr. Kercula coordinates the VaccTrain/RegTrain Project of the GHPP at the LMHRA which partnership has developed the LMHRA CT vital documents. Dr. Kercula has represented the LMHRA on several international meetings on Clinical Trials including the SCoMRA 2019 where he served as one of the speakers on Clinical Trials.

Kindly subscribe to our email listing to receive free newsletters about LMHRA and the medical sector.

LMHRA is charged with the responsibilty of protecting the Liberian populace from fake, expired and substandard medicines and health products.

Useful Links

© 2020 All rights reserved

Powered by: