Upcoming Medical Conferences in ViennaSearch Criteria : United States of America Vienna
Nov 14 - 15, 2019 | USD $1695 | Vienna, Virginia
Basic Drug Development: Overview of Biopharmaceutical Research & Development Course is organized by Pharmaceutical Education and Research Institute (PERI) and will be held from Nov 14 - 15, 2019 at Courtyard by Marriott Dunn Loring Fairfax, Vienna, Virginia, United States of America. Who Should Attend: • Professionals new to drug development • Scientific and non-scientific staff members at all levels • Members of clinical research teams • Pharmacists • Medical writers and communication specialists • Project managers and regulatory affairs personnel Description: In a blending of online and live learning, this course provides an overview of the pharmaceutical development process, from drug discovery, nonclinical and clinical development, and manufacturing, culminating in product launch and marketing. The course focuses on the decisions that need to be made throughout the therapeutic development process and the criteria influencing these decisions. The faculty for this flagship course are selected as experts in their field. The online component is PERI’s fundamental Decision Points in Pharmaceutical Development. Benefits of Attendance • Identify the basic steps in pharmaceutical development • Gain hands-on experience through practical pharmaceutical development workshops • Understand team responsibilities in pharmaceutical development • Learn key aspects and updates in the regulatory process for US, Europe and Japan Topics: • Non-Clinical Drug Development • Decision Points in Drug Development • Regulatory Review Process (FDA, EMEA) • Portfolio Review • Meeting with Regulatory Agencies • Drug & Biologic Product Manufacturing • Clinical Trial Design • Safety in the Drug Development Process • Global Considerations in Drug Development • Panel Discussion with FDA Representatives: Putting It All Together Objectives: • State the basic steps in the drug development process • Explain the difference between research and development • Discuss the key decision points in the drug development process • Explain the implications of label based drug development • Discuss the role of interaction with FDA and other regulatory agencies Additional $35 fee applies for students who are applying for continuing education credit. Additional details will be posted as soon as they are available.