Author’s Bio – Dr. Garry Mehrabian (MD):
Dr. Garry Mehrabian is a Medical Affairs / Drug safety expert. He has more than 25 years of experience in the pharma/CRO industry. Also, he gained experience working in clinical, medical affairs, and pharmacovigilance roles as a medical advisor, medical monitor, drug safety physician, clinical research physician, and medical director. Moreover, his experience covers many major therapeutic areas, including Oncology, Haematological Malignancies, Cardiovascular, CNS, Anti-Infective / HIV, and Immunology.
The roles he has held in the past include Medical Monitor at BAYER, Germany; UCB-Celltech, UK; i3 Research, UK; Cmed, UK; Neometrix Consulting, Canada; Drug Safety Physician at PAREXEL, UK; Johnson & Johnson, UK; i3 Research, UK; Eisai, UK; Chiltern, UK; Neometrix Consulting, Canada; Senior Medical Advisor/Clinical Research Physician at GSK, UK; UCB Celltech, UK; Medical Director Oncology at i3 Research, UK; Neometrix Consulting, Canada; Medical Director PVG at i3 Research, UK; and Global Director PVG at Chiltern, UK.
Author’s Bio – Dr. Afsaneh Motamed Khorasani (PhD):
Dr. Afsaneh Motamed Khorasani is a Medical Affairs expert and a Senior Scientist. Moreover, she has a strong background in biomedical science and clinical trial/research. Also, she has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing, and intellectual property.
She is currently the Vice President of Medical Affairs at Easy Global Training, a US-based firm providing global regulatory, quality, and medical affairs training backed by consulting.
Before joining this company, she served as an independent consultant, director of medical affairs, senior medical sciences liaison, scientist, and medical analyst. The companies she has worked with include Merck (MDS), Johnson & Johnson, United States Pharmacopeia Convention (USP), Amgen, Baxter International, Covidien (eV3), Radient Pharmaceuticals, AMDL Diagnostics, Microbix Biosystems, Neometrix Consulting, Mount Sinai Hospital, Princess Margaret Hospital, and Vancouver General Hospital.
She has more than 20 years of experience. Also, she has many National and international certificates in GLP, GMP, ICH-GCP, and global regulatory compliance for clinical trials. Furthermore, she is a member of several professional associations, including the American Association of Cancer Research (AACR), American Medical Writers Association (AMWA), Regulatory Affairs Professional Society (RAPS), American Society of Quality (ASQ), Project Management Institute (PMI), and Intellectual Property Institute of Canada (IPIC).
The Basics of Medical Review e-Book is specifically designed for medical monitors (MM). The purpose is to provide a comprehensive overview of the tasks and responsibilities at clinical trial sites. Most of the time, the medical monitors are medical doctors (MD). They work directly with pharmaceutical companies or contract research organizations (CROs). They contribute to designing and reviewing the protocols for proposed clinical trials. Furthermore, they build case reports or manage clinical research projects. Also, they provide specialized medical input for medically-related issues during clinical trials.
Generally, medical monitors play a critical role in the clinical trial review process. To explain, the process flow for medical review is that the Medical Monitor assigned to the task completes the medical review of the Serious Adverse Events (SAE) reports within 24 hours of receipt.
This 9-page e-Book (The Basics of Medical Review e-Book) provides a brief explanation of the role of Medical Monitoring and the importance of Medical Monitoring. Furthermore, it describes the minimum items to be included in the SAE Medical Review Form and a template to enable you to create your Medical Monitoring Forms.
By reading / following this guide (The Basics of Medical Review e-Book), you will be able to:
- Understand and define the role of Medical Monitor and Medical Review
- Understand the importance of Medical Monitoring as applicable to clinical trials
- Define and list the minimum information fields required for the SAE Medical Review Form
- And generate your own Medical Review Form following the Medical Review template provided and the material covered in this session.
Who Can Benefit From The Basics of Medical Review e-Book
- Clinical Trial Managers
- Medical Monitors
- Principal Investigators
- IRB Members
- Project Managers
- Regulatory Compliance Personnel
- Quality Control/assurance Personnel
- ID: 1365
- SKU: EB-0002-RC
- Type: e-Book
- Format: Downloadable PDF File (.pdf)
- Date of Last Update: Feb 20, 2017
- Length: 9 Pages (including the Template)
- Course Level: Moderate/Advanced
- Price: $50.00
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