Drug Development 101 – How A Drug Is Made

Teachers
Albert Yehaskel
Category:
Clinical Trials/Manufacturing/Regulatory & Compliance/Research & Development/Upcoming Live Courses/Introductory Courses/
Clear
Duration: 90 minutes
November 14, 2018 | 1 PM EST
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 will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days). Access instructions for the live viewing will be emailed to you 3 business days prior to the scheduled date. Access to the recorded version will be available 1 business day after the live course has run.

To access the course, you need only a telephone and computer with internet access.

This webinar is scheduled for live instruction on
Date: November 14, 2018
Time: 1:00 – 2:30 PM EST

Choose to participate live or listen to the recording afterward!

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.

The recorded version of the training will be available for 30 days after purchase.

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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