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US-FDA Drug Submission Procedures

PTI
Course summary
2 days
1,595 GBP excl. VAT
Professional Training
Next available date: 03/08/2020 - Online courses
Course Dates
Online courses
03/08/2020  
1,595 GBP
03/08/2020  
1,595 GBP

Course description

US-FDA Drug Submission Procedures

US-FDA Drug Submission Procedures - 2-day Pharma Training Course by PTI

This course is designed to help you gain a better understanding of the US regulatory process. By attending this extensive two day course, you will be able to gain a practical insight into FDA’s requirements for new drug development and prepare your new drug registration dossier accordingly to US guidelines. By the end of this two-day course you will be able to:

  • Prepare complete dossiers by understanding the crucial elements of US INDs and NDAs
  • Meet the data requirements for INDs and NDAs
  • Communicate better with the FDA by knowing the organisational structure of the Agency and the interactions within the agency
  • Work your way through the laws and regulations governing the registration of prescription drugs in the US
  • Know how to obtain information from the FDA
  • Understand the logistics of the sponsor-FDA interactions

LIVE ONLINE ACADEMIES

In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. 

Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-2 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Suitability - Who should attend?

This training programme is aimed at professionals specialising in Regulatory operations within the pharma industry:

  • Compliance Managers
  • Documentation Managers
  • Product Registration Personnel
  • Project Managers in Regulatory Affairs
  • Marketing Managers
  • Clinical Research Personnel
  • Key contributors to the submission package for the US market

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

Expenses

The cost of this training course is £1595 + VAT per participant, which covers tuition and course materials.

In-house Training

PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...


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Contact info

PTI

London

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http://www.pti-global.co.uk

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