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Browsing by Author "Salek, Sam"
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Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry
Owusu-Asante, Mercy; Darko, Delese Mimi; Walker, Stuart; Salek, Sam (2023-05-09)Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current ... -
Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries
Owusu-Asante, Mercy; Darko, Delese Mimi; Walker, Stuart; Salek, Sam (2022-11-25)Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and ... -
Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization of Biosimilar Medicines in BRICS-TM Countries: An Exploratory Study
Rahalkar, Hasumati; Sheppard, Alan; Lopez-Morales, Carlos Augusto; Lobo, Luciano; Salek, Sam (2021-07-22)Abstract: Background: Biosimilars are expected to emerge as a rapidly growing segment of the biopharmaceutical industry. However, the biosimilar industry faces multiple challenges and obstacles in developing and marketing ... -
Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices
Rahalkar, Hasumati; Sheppard, Alan; Salek, Sam (2021-08-09)Objectives: The aim of this study was to identify, compare and evaluate regulatory requirements for the biosimilar development and review processes in BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, Mexico) ... -
A comparison of reimbursement recommendations by European HTA agencies : Is there opportunity for further alignment?
Allen, Nicola; Liberti, Lawrence; Walker, Stuart R.; Salek, Sam (2017-06-30)Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement ... -
Comparison of the registration process of the Medicines Control Authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: Benchmarking best practices
Sithole, Tariro; Salek, Sam; Mahlangu, Gugu; Walker, Stuart (2021-10-20)Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving ... -
A cross‐sectional study of the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across the Middle East and Africa ( PACT‐MEA ): Study design and rationale
Verma, Subodh; Sabbour, Hani; Alamuddin, Naji; Alawadi, Fatheya; Alkandari, Hessa; Almahmeed, Wael; Assaad‐Khalil, Samir H.; Haddad, Jihad; Lombard, Landman; Malik, Rayaz A.; Mashaki Ceyhan, Emel; Prasad, Preethy; Tombak, Gamze; Salek, Sam (2023-03-03)Aim: To investigate the epidemiology and clinical management of patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (eASCVD) or high/very high ASCVD risk, defined by the 2021 European ... -
Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities
Rahalkar, Hasumati; Sheppard, Alan; Santos, Gustavo Mendes Lima; Dasgupta, Chitralekha; Perez-Tapia, Sonia Mayra; Lopez-Morales, Carlos A.; Salek, Sam (2021-09-09)Background: The aim of the study was to identify, interpret, and compare the current perspectives of regulatory agencies in six member countries of BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, and Mexico) ... -
Development of a Consumer Reported Outcome Measure for Personal Care Products : The Rationale
Falcone, Robert; Umaru, Nikkie; michniak-kohn, Bozena; Salek, Sam (2024-01-30)Background: Cosmetic products are one of the fastest-growing segments of personal care products in the United States. One of the critical elements in the sales and growth of cosmetics is leveraging claims. Unlike pharmaceuticals ... -
Development of a Novel Hematological Malignancy Specific Patient-Reported Outcome Measure (HM-PRO) : Content Validity
Goswami, Pushpendra; Oliva, Esther; Ionova, Tatyana; Else, R; Kell, J; Fielding, AK; Jennings, DM; Karakantza , M; Al-Ismail, S; Collins, GP; McConnell , S; Langton, Catherine; Salek, Sam (2020-03-05)Background: The quality of life of patients at all stages of hematological malignancy is greatly affected by the disease and its treatment. There is a wide range of health-related quality of life (HRQoL) issues important ... -
Development of the Pyruvate Kinase Deficiency Diary (PKDD) and Pyruvate Kinase Deficiency Impact Assessment (PKDIA): Disease-Specific Assessments
Salek, Sam (2019-12-27)INTRODUCTION: Currently recommended patient-reported outcome (PRO) measures for patients with pyruvate kinase (PK) deficiency are non-disease-specific. The PK Deficiency Diary (PKDD) and PK Deficiency Impact Assessment ... -
Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward
Ngum, Nancy; Mashingia, Jane; Ndomondo-Sigonda, Margareth; Walker, Stuart; Salek, Sam (2022-07-05)Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical ... -
Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for improvement
Ngum, Nancy; Mashingia, Jane; Ndomondo-Sigonda, Margareth; Walker, Stuart; Salek, Sam (2022-11-03)Background: A 2021 study to determine the viewpoints among the seven member countries regarding the effectiveness (i.e., achieving the intended outcomes) and efficiency (i.e., achieving the intended outcomes in timely ... -
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities
Owusu-Asante, Mercy; Darko, Delese Mimi; Asamoah-Okyere, Kwame Dei; Asante-Boateng, Samuel; Kermad, Adem; Walker, Stuart; Salek, Sam (2023-03-31)Purpose: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and quality decision-making ... -
Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward
Sithole, Tariro; Mahlangu, Gugu; Capote, Velma; Sitoie, Tania; Shifotoka, Saren; Gaeseb, Johannes; Padayachee, Silverani; Sehloho, Tohlang; Khea, Akida; Fimbo, Adam; Munkombwe, Zuma; Mwale, Bernice; Salek, Sam; Walker, Stuart (2021-08-27)Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the ... -
Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities
Danks, Lorraine; Semete-Makokotlela, Boitumelo; Otwombe, Kennedy; Parag, Yashmika; Walker, Stuart; Salek, Sam (2023-10-23)Introduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients’ access to medicines. This study considered whether reliance ... -
Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward
Sithole, Tariro; Mahlangu, Gugu; Capote, Velma; Sitoie, Tania; Shifotoka, Saren; Gaeseb, Johannes; Danks, Lorraine; Nkambule, Portia; Juma, Alex; Fimbo, Adam; Munkombwe, Zuma; Mwale, Bernice; Salek, Sam; Walker, Stuart (2021-08-27)Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and ... -
Guidelines for the Use and Reporting of Patient-Reported Outcomes in Multiple Myeloma Clinical Trials
Laane, Edward; Salek, Sam; Oliva, Esther Natalie; Bennink, Christine; Clavreul, Solène; Richardson, Paul G; Scheid, Christof; Weisel, Katja; Ionova, Tatyana (2023-12-08)Simple Summary: It is recognized that patients with multiple myeloma (MM) experience a high burden of disease and treatment-related symptoms that impact upon their quality of life (QoL). In these patients, patient-reported ... -
Haematological malignancy: are we measuring what is important to patients? A systematic review of quality of life instruments
Goswami, Pushpendra; Khatib, Yasmin; Salek, Sam (2019-04-01)The wide range of health‐related quality‐of‐life (HRQoL) instruments used in haematology makes it challenging for haematologists and other care team members in practice to select, use and understand the scoring system and ... -
Health Technology Assessment (HTA) Case Studies : Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland
Allen, Nicola; Walker, Stuart R; Liberti, Lawrence; Salek, Sam (2017-03-31)OBJECTIVES: To evaluate the national regulatory, health technology assessment (HTA), and reimbursement pathways for public health care in Australia, Canada, England, and Scotland, to compare initial Canadian national HTA ...