Regulatory sciences and quality Posters

TUESDAY 26 SEPTEMBER

RSC-001 Risks in medical device vigilance
Ms Danielle Claire Almojero1, Dr Maresca Attard Pizzuto1, Prof Anthony Serracino-Inglott1
1Department of Pharmacy, University Of Malta, Msida , Malta

RSC-002 A systematic review of pharmacist ability to independently perform CLIA-waived tests in the United States
Dr Julie Akers1, Dr Kimberly McKeirnan1, Dr. Donald Klepser2, Dr Michael Klepser3, Dr Kenneth Hohmeier4, Dr Steven Cagas5, Dr. Cameron James5, Dr Mitra Sadeghi5
1Washington State University, Spokane, United States, 2University of Nebraska Medical Center, Omaha, United States, 3Ferris State University, Big Rapids, United States, 4University of Tennessee Health Science Center, Nashville, United States, 5Genentech, Inc., South San Francisco, United States

RSC-003 Guidelines for quality control of medical cannabis
Mr Julian Mifsud1, Doctor Janis Vella Szijj1, Prof Lilian M. Azzopardi1
1Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, , Malta

RSC-004 A phase iIa clinical trial of KAND567, fractalkine receptor inhibitor, in patients with ST-elevation acute myocardial infarction undergoing percutaneous coronary intervention
Ms Yasemin Ekinci1, Professor Ioakim Spyridopoulos1,2, Dr Gavin Richardson1
1Newcastle University, Newcastle Upon Tyne , United Kingdom, 2Cardiology Department, Freeman Hospital, Newcastle Upon Tyne , United Kingdom

RSC-005 Challenges in establishing a sustainable official medicines control laboratory in a small member state
Ms Elaine Gatt Baldacchino1, Dr Louise Grech2, Prof Anthony Serracino Inglott3
1University of Malta and Malta Medicines Authority, Msida, Malta, 2University of Malta and Malta Medicines Authority, Msida, Malta, 3University of Malta and Malta Medicines Authority, Msida, Malta

RSC-006 Quality of medicines for the prevention and management of hypertensive disorders of pregnancy: a systematic review
Ms Pooja Maharjan1, Dr. Annie McDougall2, Miss Meghna Prasannan Ponganam1, Prof. Joshua P. Vogel2, Mr. Pete Lambert1, Prof. Michelle McIntosh1
1Monash University, 381 Royal Parade, Parkville, VIC 3052, Australia, 2Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia

RSC-007 Auditing in a medicinal regulatory framework
Mrs Valentina Sammut1, Professor Anthony Serracino Inglott1
1Malta Medicines Authority, Mellieha, Malta

WEDNESDAY 27 SEPTEMBER

RSC-010 The stability of dabigatran etexilate (Pradaxa®) capsules in dose administration aids
Dr Ayman Allahham1
1Rmit University, Bundoora, Australia

RSC-011 Knowledge gaps for adverse drug reaction reporting by traditional medical practitioners in Kaduna, Nigeria
Dr Mustapha Mohammed1, Mrs Fatima Umar I1, Dr Sagir Mustapha2, Dr Abubakar Wada S3, Dr Surajuddeen Muhammad4, Dr Aishatu Shehu2, Dr Elijah Mohammed NA5
1Department of Clinical Pharmacy and Pharmacy Practice, Ahmadu Bello University, Zaria, Nigeria, 2Department of Pharmacology and Therapeutics, Ahmadu Bello University, Zaria, Nigeria, 3Department of Pharmacology and Therapeutics, Bayero University Kano, Kano, Nigeria, 4Faculty of Veterinary Medicine, Ahmadu Bello University, Zaria, Nigeria, 5Faculty of Pharmacy, University of Benin, Benin City, Nigeria

RSC-012 Development of simple colorimetric method on the determination of dexamethasone in herbal medicine
Dr Rimadani Pratiwi1, Adira Rahmawaty1, Vandie Charlie1, Driyanti Rahayu1, Prof. Aliya Nur Hasanah1
1Department of Pharmaceutical Analysis and Medicinal Chemistry, Faculty of Pharmacy, Universitas Padjadjaran, Bandung, Indonesia

RSC-013 Comparative analysis of the regulatory guidelines for clinical trials in regulated and semi-regulated countries: Botswana, India and the US-FDA
Ms Tshetsana Senau1
1Botswana Medicines Regulatory Authority, Gaborone, Botswana, 2University of Nicosia, , Cyprus

RSC-014 Global evaluation on the impact of the BERC-Luso Project
Maria do Céu Patrão Neves1, Maria Alexandra Ribeiro2, Officer Jorge Batista3, Helder Mota-Filipe4, Joana Araújo5, Ms Leonor Soares6, Jocelyne Vasconcelos7, Ester Delgado Oliveira8, Victor Francisco Gomes9, Telma Chicuamba10, Vãnia Castro11
1Professor of Ethics; Member of the World Emergency COVID 19 Pandemic Ethics; BERC-Luso Project Coordinator, S. Miguel, Açores, Portugal, 2President of the National Ethics Committee for Clinical Research and Vice President of EUREC, Lisboa, Portugal, 3BERC-Luso Project Executive Manager; Portuguese Pharmaceutical Society, Lisboa, Portugal, 4Associate Professor at Faculty of Pharmacy, University of Lisbon; President of the Portuguese Pharmaceutical Society; Portugal, Lisboa, Portugal, 5Expert in Bioethics; BERC-Luso Project Assistant, Porto, Portugal, 6Executive secretary of the Portuguese Pharmaceutical Society, Lisboa, Portugal, 7Head of the Health Research Centre of Angola (CISA), , Angola, 8Techncian of the Pharmaceutical regulation Directorate of the Independent Health RegulatoryAuthority of Cape Verde, , Cape Verde, 9Member of National Ethics Committee for Health of Guinea-Bissau, , Guinea-Bissau, 10Head of the Clinical Trials Division in the Department for the Evaluation of Medicines, Vaccines,Biologicals and Health Products of Mozambique, , Mozambique, 11Responsible for inspection, licensing and pharmacovigilance services in the Pharmaceutical Department of the Ministry of Health of Sao Tome and Principe, Sao Tome and Principe, , Sao Tome and Principe

RSC-015 Evaluation of thalidomide education and risk management system (TERMS) in Japan: Patients’ responses to a third-party survey on comprehension, compliance, and concerns from 2009 to 2019
Mr. Hiroki Kawase1, Dr. Yu-Shi Tian1, Ms. Yui Nojima1, Ms. Haruka Asano1, Dr. Yuko Shirakuni1, Dr. Tomoaki Ichijo2, Ms. Megumi Tsukamoto1, Prof. Masao Nasu3, Prof Tatsuya Takagi1
1Graduate School of Pharmaceutical Sciences, Osaka University, Suita, Japan, 2Department of Health and Nutrition, Osaka Shoin Women’s University, Higashi-Osaka, Japan, 3Graduate School of Pharmacy, Osaka Ohtani University, Osaka, Japan

RSC-016 Medicine quality post-market authorization in a suburban city in Sri Lanka: In-vitro pharmaceutical quality assessment of three medications dispensed by the public and private sectors
Mrs Manori Jayasinghe1, Ms. Hasinduni Madhushika2, Ms. Ishani Anuruddhika3, Ms. Gayashani Pramodika4, Mr. Sasanka Priyanath5, Mrs. Kanchana Wijesekara6, Dr. Sewwandi Subasinghe7
1University of Ruhuna, Karapitiya, Sri Lanka, 2University of Ruhuna, Karapitiya, Sri Lanka, 3University of Ruhuna, Karapitiya, Sri Lanka, 4University of Ruhuna, Karapitiya, Sri Lanka, 5University of Ruhuna, Karapitiya, Sri Lanka, 6University of Ruhuna, Karapitiya, Sri Lanka, 7University of Ruhuna, Karapitiya, Sri Lanka