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:
- Clinical Database Management
Location: Osaka,Japan
Session Introduction
Chi Chen
Partner at E&Y,CHINA
Title: Data Integrity: What the Government Wants, and How Technology May Help
Biography:
Chi Chen is a forensic technology partner in EYs Forensic & Integrity Services practice. He specializes in predictive risk analytics, proactive compliance monitoring, and management systems, trade compliance, data compliance, IP and personal data privacy protection, fraud detection analytics, antitrust analytics, and eDiscovery. All of which require in-depth analysis of large, disparate sets of financial, operational and transactional data. Chi led his team to help clients identify high-risk transactions or behaviors timely, efficiently, and effectively by leveraging advanced data analytics techniques including but not limited to data visualization, statistical modeling, text mining, and machine learning. Chi has more than 16 years of combined advisory and audit experience in the United States, Australia and China. He has served many Fortune 500 and multinational companies in a variety of industry sectors including life sciences.
Abstract:
Rajiv Joshi
Director and Assurance,E&Y
Title: Data Integrity: What the Government Wants, and How Technology May Help
Biography:
Rajiv is a Partner with EY’s Forensic & Integrity Services practice in India. He has more than 12 years of professional experience and has led various investigations across sectors such as life sciences, retail and insurance. He specializes in enterprise risk management, investigations, revenue assurance program, channel reviews, supply chain management, internal audit and compliance. He has previously worked with Reliance Retail and ICICI Prudential Life Co. Rajiv is also the author of the IIA India 1st publication, “Internal Audit of Intangible Assets”. He is based in Mumbai.
Abstract:
Md.Gayoor khan
Truba institute of Pharmacy Bhopal Madhya Pradesh, India
Title: A study to compare efficacy of Metformin-Glimepiride versus Metformin-Tenelig liptinin Type II Diabetic Patients
Biography:
Abstract:
Biography:
Carole Gabay is a veteran in Market Analytics and Market Research, as she started her career at age 22 with Nielsen in France and stayed in the field all her career, mainly on client side, but with a variety of geographies, organizations, and industries.
After 10 years in the FMCG industry, she has spent the last 15 years developing expertise in Primary research and Market Analytics in the Pharmaceutical industry for BMS EMEA, Bayer in Japan, Novartis and Vifor Global HQs in Switzerland. She has strong expertise in syndicated market information including patient records studies used at Global and country levels.
She lives In China since 2013, after assignments with IPSOS Healthcare and Sanofi, She builds on her experiences to enhance analytical processes on market information with an extension to internal activity / CRM data, in partnership with digital Healthcare marketing agency DRCOM
Abstract:
- Adverse Drug Effects
Location: Osaka,Japan
Chair
Md.Gayoor khan
Truba institute of Pharmacy Bhopal Madhya Pradesh, India
- Patient records studies : for Pharma companies and for science
Location: Osaka,Japan
Chair
Carole Gabay
- Good Pharmacovigilance Practise
Location: Osaka,Japan
Session Introduction
Fawad Piracha
Regeneron Pharmaceuticals, Inc,USA
Title: Guideline on Good Pharmacogivilance Practices (GVP) Module V – Risk Management Systems (Revision 2) – Updates and Feedback
Biography:
Dr. Fawad Piracha, Pharm.D., R.Ph. completed a post-doctoral fellowship in Pharmacovigilance and Risk Management at Regeneron Pharmaceuticals, Inc. in Tarrytown, NY, in April 2017. He currently assumes responsibilities in risk management for early and late stage clinical development programs in infectious diseases and immuno-oncology programs at Regeneron. He became a licensed pharmacist in New York State in August 2016 and received his Doctor of Pharmacy degree from St. John's University College of Pharmacy and Health Sciences in May 2016.
Abstract:
- Drug Safety
Session Introduction
Abeer Muhanna
Saudi Patient Safety Center, Saudi Arabia
Title: Pharma-Safe†Medication Safety Best Practice Standards in community pharmacy
Biography:
Abeer Muhanna is a Medication Safety program team leader at Saudi Patient Safety Center, Riyadh Saudi Arabia. She is holding American Board certification in Pharmacotherapy specialty and a Master Degree in Clinical Pharmacy. She has 12 years of experience as a clinical pharmacist an 8 years experience as a quality and Medication safety expert. She is working as a Medication Management Surveyor at CBAHI (National accreditation body in Saudi Arabia)
Abstract:
Ashok Srivastava
CEO of Cure Pharmaceuticals, and ClinFomatrix Oncology,USA
Title: Challenges in Breast Cancer Treatment and Long-Term Drug Safety
Biography:
Dr. Ashok Srivastava is Chief Executive Officer and Chief Medical Officer of Cure Pharmaceuticals, and ClinFomatrix Oncology CRO, He was founder, Chief Executive Officer and Chief Medical Officer of Care Beyond - A Radiation Therapy Cancer Center, New Jersey. USA. He has more than 15 years of experience in drug development, medical affairs and commercialization of cancer drugs including radiopharmaceutical and supportive care; Phase 1 – 4, and marketing commercialization of Hematology, Oncology and radio-immuno-oncology drugs in USA, EU and Japan. He is leader in Cancer Drug Development Worldwide large and complex Phase 3 Clinical Trials.
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.