The Advancement of Clinical Trials in South Africa during and Post-Covid-19 Era
Webinar Speaker Line Up
Dr. Clare L. Cutland [BSc., MBBCH, DCH, PhD (Wits)]
Scientific coordinator, African Leadership in Vaccinology Expertise (ALIVE),
University of the Witwatersrand.
Clare Cutland is the Scientific Coordinator of the African Leadership in Vaccinology Expertise (Alive) consortium, which is led by co-directors Professors Helen Rees (Wits RHI) and Shabir Madhi (VIDA/ RMPRU). ALIVE was selected as the flagship entity for the University of the Witwatersrand in 2016, and aims to create African expertise and leadership in vaccinology training, research and advocacy.
Prior to her appointment in ALIVE (Nov 2018), she was a research medical officer and subsequently the deputy director of the Respiratory and Meningeal Pathogens Research Unit (RMPRU), based at Chris Hani Baragwanath Academic Hospital (CHBAH), Soweto, South Africa (2000-2018).
TOPIC FOR DISCUSSION:
COVID-19 vaccine trials: An overview of the vaccine trial that is being conducted at Wits.
Thanyani Nathaniel Ramuthaga [Med.Sci. & Pr. Sci. Nat, B.Sc. (Unin) BSc Hons. MSc. (MEDUNSA)
Innovative Pharmaceutical Association of South Africa [IPASA Representative]
Nat has been involved in Pharma since 1995, Clinical Research Associate/ Senior CRA (CRA): Pfizer Pharmaceuticals: Brand/Product Manager; Clinical Research Manager; Director of Clinical Research, Senior Regional Head of Clinical Operation - Africa & Middle East; Sr. Director Compliance Oversight for Africa Middle East;
Principal Compliance Officer General Pharmaceutical Health care consulting as Council Member of the Global Gerson Lehrman Group (GLG) Inc. and Guide point International.Served as a member of the SA Regulatory Authority’s Medicines Control Council (MCC/ SAHPRA in 2017/18)’s Clinical Trials Review Committee (CTC) as an Independent Protocol Reviewer.
Currently working at Roche as PDG Country Head of Clinical Operations South Africa and Sub-Sahara and serves as a member of IPASA Clinical Trials Group.
TOPIC FOR DISCUSSION:
i. Clinical Trials Pipelines for Pharma: A shift in global forecastingand investment due to the unexpected COVID-19.
ii. How this affects Clinical studies coming to South Africa, from a Pharma & CRO perspective
Alex Lopes
Country Head -South Africa
Novartis South Africa [Local Pharma Representative]
Alex has 14 years’ experience in clinical development, starting his career in Statistical Programming, spending 3 years on assignment with GSK in the United Kingdom. Thereafter, he returned to South Africa, taking various clinical operations positions at international CROs, including CRA, study and people management roles. In January 2018, he joined Novartis as the Trial Monitoring Country Head for South Africa, and over the past 18 months has overseen the expansion of the company’s clinical trial footprint into Sub-Saharan Africa, which now also falls under his responsibility.
TOPIC FOR DISCUSSION:
i. Clinical Trials Pipelines for Pharma: A shift in global forecastingand investment due to the unexpected COVID-19.
ii. How this affects Clinical studies coming to South Africa, from a Pharma & CRO perspective
Dr Essack Mitha
Principal Investigator | Clinical Trials & Pharmaceuticals
Newtown Clinical Research Centre
Has more than 16 years’ experience in Research and Development (Clinical Trials) in the Medical and Pharmaceutical sectors, working with both local and international companies in the conduct of 100+ clinical trials.
Is a registered and practicing general medical practitioner, with additional Diplomas in Obstetrics and Emergency Gynaecology and completed emergency care courses (ACLS and APLS). Completed courses in Ethics of Research with Human Subjects and Understanding Clinical Research: Behind the statistics. Currently serves as a reviewer for DTMS Health Research Ethics Committee, and an Executive Committee member of SACRA (South African Clinical Research Association).
TOPIC FOR DISCUSSION:
i. Site strategies under the new normal.
ii. Local Public Health care facilities: Johannesburg’s perspective on management of COVID-19
Marzelle Haskins
Managing Director
Pharma-Ethics
Marzelle Haskins graduated from the University of Pretoria in 1996 with an LLB degree in law. Since 1995 she was employed by Clindepharm International which was later bought by a Global Contract Research Organisation, Quintiles. Her duties included clinical trial monitoring and auditing of several multi-national clinical trials. In 1998 she became involved with Pharma-Ethics Research Ethics Committee (REC) and in 2003 she left Quintiles for a full-time position at Pharma-Ethics, where she is responsible for managing the REC.
She is also a voting member of the REC. In 2006 she was elected as a member of the National Health Research Ethics Council (NHREC) of South Africa and was re-elected in 2010. Marzelle was the chair of the NHREC working group for the Registration and Auditing of RECs in South Africa. She is actively involved in training of Research Ethics Committee Members in Southern Africa and is currently a partner in various EDCTP grants focusing on capacity building of ethics and regulatory review in Africa.
TOPIC FOR DISCUSSION:
The changing landscape in which Clinicals Trials and Ethical approaches find themselves and the adjustments that have to be made as we go forward with Clinical Research currently and into the future.
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