Day 1 :
Keynote Forum
Jacob Joseph
Haward Medical School,USA
Keynote: Pragmatic Clinical Trials - Hope or Hype
Biography:
Dr. Jacob Joseph is an Associate Professor of Medicine at Harvard Medical School. Dr. Joseph, as director of the Clinical Research Partnerships and Innovations program based at Massachusetts Veterans Research and Information Center, focuses on streamlining the clinical trial process and rendering participation in clinical trials easier for patients, clinician researchers, research sites and research sponsors. He provides leadership to three ongoing large multinational clinical trials (INVESTED, PROMINENT and GALACTIC-HF), serving as the lead for national VA networks for these trials as well as serving as a member of the Executive and Steering committees. His research also focuses on heart failure, utilizing national patient care databases to conduct deep phenotyping studies of heart failure, especially heart failure with preserved ejection fraction. Dr. Joseph also conducts translational research on the mechanisms and treatment of myocardial fibrosis.
Abstract:
Keynote Forum
Ujwala Vilas Salvi
Nucleon Therapeutics LLP, Mumbai (India)
Keynote: Deep Dive in aspects of Pharmacovigilance for Biologics, Bio-Similar and Vaccines
Time : 9:55
Biography:
Dr. Ujwala V. Salvi has over 15 years of experience across the Global and local Pharmaceutical/CRO, Tier I Medical Devices and BPO industry.
She is Doctorate in Applied Biology & MBA in Healthcare from Indian Institute of Management, Kolkata. QPPV for Nucleon Therapeutics, Trained in Six Sigma Black Belt and various Project management tools, with core experience in a wide range of Therapeutic Areas, and worked at all stages of clinical development from Phase II to production of clinical documentation necessary for product license applications. She has worked in large global operations, managed strategic relationships, and played a key role in winning new business, setting up off-shored partnerships and in identifying new BU service lines and growing existing ones.
Her areas of expertise include Pharmacovigilance, Clinical Data Management, Clinical Trial operations, Risk Based Monitoring, Medical Writing and data publication, and feasibilities of new drug development and Analytics.
She is an industry expert, has been involved in key global industry forums such as the DIA, SCDM, CII and CPHI.
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:
- 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.