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HomeManufacturing & Good Manufacturing Practices (GMP) TrainingThe Investigational New Drug (IND) Submission – Tips to Win the First Time

The Investigational New Drug (IND) Submission – Tips to Win the First Time

Teachers
Albert Yehaskel
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Regulatory & Compliance/
3 Reviews
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Duration: 90 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

An Investigational New Drug (IND) submission is the first major effort in a long line of regulatory product filings to receive FDA marketing approval.  A high-quality IND submission is imperative as this will be your first real impression with FDA, and a substandard effort will stall the process and lead to costly regulatory delays.  It is important to obtain the cooperation of several disciplines either within the organization or outside consultants when writing and assembling an IND, which include staff in non-clinical, clinical, CMC/manufacturing, and regulatory affairs.  These disciplines will play pivotal roles in guaranteeing the submission is complete and on-time for filing.   Most importantly, an understanding of what it takes to assemble the various components of a successful IND – a step-by-step procedure – will give you an opportunity to stand out in the eyes of FDA.

LEARNING OBJECTIVES

This course will enable the you to have an appreciation/understanding of the IND process that includes:

  1. Project planning – managing timelines, mitigating risk
  2. Work teams – getting the right people working on the right parts of the submission
  3. Introduction to FDA interactions – What to say, what not to say
  4. Structured review process across disciplines – building organization and accountability
  5. Working in an electronic environment

Additionally, this course will cover some of the following challenges:

  1. The pre-IND meeting with FDA (ensuring your initial success with the Agency)
  2. Preparing a high quality and comprehensive IND…step-by-step
  3. Investigator’s Brochure
  4. Clinical Protocol
  5. CMC information – how much is enough
  6. Pharm/Tox Information
  7. Previous Human Experience
  8. Versioning and preparing to publish your IND
  9. Submitting and Maintaining the IND – keeping the Agency informed

Who Should Attend

WHO SHOULD ATTEND

This course will benefit anyone in regulatory affairs, CMC/manufacturing, clinical, document management, and project planning.  Additionally, anyone who needs a working knowledge of the IND process should attend.

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.
  • Vineetha Edavana

    8 months ago

    I am interested in attending this course

  • Vineetha Edavana

    8 months ago

    I am interested in attending this course. please share more details.

  • Jeff Parke

    7 months ago

    this is perfect for consultants working with emerging biotech

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Duration: 90 minutes
On-Demand
Includes handouts

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Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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