Day 2 :
Keynote Forum
Meenal Patwardhan
AbbVie,USA
Keynote: Internal Safety Advisory Groups (ISAG): A Win-Win for Effective Decision-Making in Biopharmaceutical Companies
Time : 9:30
Biography:
Therapeutic Area Head, Infectious Diseases, Neurosciences, Men and Women's Health, General Medicine and Medical Director, Product Safety Leader, Abbott/AbbVie Senior Medical Director, Product Safety Leader, Abbott/AbbVie.In 2001, she worked as Adjunct Associate Professor of medicine at Duke University Medical center.
Abstract:
Keynote Forum
Assem S. el Baghdady
Managing Director, AlphaBeta Pharma
Keynote: Under-representation of vulnerable population in clinical trials impacts negatively on drug development and safety evaluation of new medicine
Biography:
Assem el Baghdady, MD, MBA is a pharmaceutical physician consultant with over 20 years of experience in clinical research.
Co-founder & Managing Director of AlphaBeta Pharma, a consulting firm providing consultancy for R&D strategy, interim-management, expert clinical review, risk-management advice, due-diligence & technology-transfer.
He graduated from Cairo, Egypt and trained in Ireland at Richmond Institute of Neurological Sciences in Dublin, joined the Academic Department of Clinical Neurology at University of Sheffield, UK, as a Clinical Research Fellow/Lecturer, continue his research and training in Clinical-Neuroscience and Cognitive-Psychology.
He has held senior executive roles in R&D in pharmaceutical and biotech companies including AstraZeneca, Wyeth, Novartis, Kiowa Kirin, Roche and UCB.
Assem also holds a Visiting Senior Lecturer position in Pharmaceutical Medicine at King’s College London, and Directorship of Innovation & Technology-transfer at University of San Agustin, Philippines.
He is an invited speaker at many national / international platforms and author of few papers / book-chapters, most recently “Clinical Trials of Medicines in the Elderly” chapter in Clinical Research Manual text book published January 2017, and Editor of “Monoclonal Antibodies: History, Mechanism and Applications” text book [in press].
Abstract:
- Adverse Drug Effects
Session Introduction
Zhou (Tom) Hui
Senior Principle Scientist – Medical Safety at Takeda, USA
Title: Integrating Regulatory Drug Label Information to Facilitate Evaluation of Adverse Events in Pharmacovigilance
Biography:
Zhou (Tom) Hui has a MD in Clinical Medicine from Nanjing Medical University and MS in Biomedical Engineering from University of Texas Southwestern Medical Center at Dallas. He is a Senior Principle Scientist – Medical Safety at Takeda, a premier pharmaceutical company. He has published 2 papers recently in the field of Pharmacovigilance and Productivity Management
Abstract:
Abdeen Omer
Ministry of health, UK
Title: Some aspects of Fake and counterfeiting of drugs: Sudan case
Biography:
Abdeen Mustafa Omer (BSc, MSc, PhD) is an Associate Researcher at Occupational Health Administration, Ministry of Health and Social Welfare, Khartoum, Sudan. He has been listed in the book WHO’S WHO in the World 2005, 2006, 2007 and 2010. He has published over 300 papers in peer-reviewed journals, 200 review articles, 7 books and 150 chapters in books.
Abstract:
- Drug Safety
Session Introduction
Fathima Atima Yousef Ali Ghethan
King Abdullah Medical City,Saudi Arabia
Title: Medication Safety in Health care Facility
Biography:
Ph. Fatima Yousef Ali Ghethan: Master degree pharmacology “University of Jordan”, Head of Quality and Medication safety unit King Abdullah Medical City, Certified Medication Safety Officer from AIHQ USA, Certified key Performance Indicator Professional From KPI Institute Australia, Certified key Performance Indicator Practitioner From KPI Institute Australia , certificate Patient safety Program John’s Hopkins
Abstract:
Essam Ghanem
Head of Pharmacovigilance, Celyad Biopharmaceutical (Immuno-oncology), Belgium
Title: Monitoring Pharmacovigilance quality system is important indicator for pharmaceuticals’ compliance.
Biography:
Dr. Essam Ghanem is an experienced physician and European Qualified Person for Pharmacovigilance (EU-QPPV). Around 28 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Contractual Research Organisations. Almost 8 years working experience as EUQPPV and international speaker in the field of Pharmacovigilance system compliance and risk mitigation. At present time, Essam Ghanem is the head of pharmacovigilance at Celyad Biopharmaceutical (Immuno-oncology), Belgium.
Abstract:
Dr Ripal Gharia
Cliantha Research Limited, Ahmedabad, India
Title: Clinical Trial Safety Monitoring: Requirement of eSAE system
Biography:
Dr. Ripal Gharia has completed her MD in Pharmacology at the age of 25 years from Bhavnagar University in India. She is Assistant General Manager – Pharmacovigilance & Medical Services at Cliantha Research Limited, a premier Clinical Research organization. She has wide experience in medical writing, regulatory affairs, pharmacovigilance, and clinical trial management. Extensive knowledge of various areas, including protocol writing, medical statistics, regulatory requirements, site management and data generation and interpretation.