Drug Development 101 – How A Drug Is Made

Teachers
Albert Yehaskel
Category:
Clinical Trials/Introductory Courses/Manufacturing/On Demand Courses/Regulatory & Compliance/Research & Development/
Clear
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Bringing a new pharmaceutical product from the laboratory to the pharmacy requires years of bench research, and nonclinical research to assess the safety profile of the new drug.  The next phase is careful clinical research on human subjects to assess the safety and efficacy of your product, constant interactions with FDA, manufacturing your product in the most efficient manner compliant with the appropriate regulations, and finally assembling a high-quality application that will be accepted and approved by the FDA.

Each of these steps requires a clear focus and is time and labor intensive.  Your handling of the process can potentially accelerate, delay, or derail the approval process.

Good project management and excellent communications with FDA will enable your company to ensure timelines are met. The development plans that you craft will be your roadmap to ensuring you stay on course, or seek alternate routes whenever speedbumps present themselves.  This course will enable you to have an appreciation/understanding of the critical processes associated with drug development

LEARNING OBJECTIVES

This course will cover the following areas of new drug development and associated challenges…

  1. Preclinical research
  2. Preparing for the Pre-IND
  3. Opening an IND
  4. Clinical Research (Phase 1, 2 and 3)
  5. Development Plans
  6. Pediatric studies
  7. Posting your clinical trials to Clinicaltrials.gov
  8. Interactions with FDA to discuss your drug development
  9. Assembling the New Drug Application

Who Should Attend

WHO SHOULD ATTEND

This course will benefit anyone in drug development, regulatory affairs, management and project planning, pre-clinical, clinical CMC , Quality, and marketing personnel. Additionally, anyone looking for a high-level overview of “how a drug gets made” will find this course extremely valuable.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Albert Yehaskel
Focused on solving New Drug Development issues for small and medium sized companies.

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