Webinar On Drug Development & Discovery by FDA Standards

Description :

The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular piece of discovery or development. You can spend a lifetime in your part of the process, without ever understanding the complete picture. While you may hear or see the other parts by interacting with colleagues from other parts of the process you never quite get the whole picture. Add to that, that different regulatory agencies have different requirements and it often feels like pieces of a jigsaw puzzle which you see at random, never quite understanding how they all fit together to get the big picture.

This leaves you confused, causes friction between departments and leaves the company prone to errors and mishaps that can be avoided if you understood what the other parts of the company and an FDA inspector require of you. This in turn results in delayed timelines, product recalls and operational inefficiencies.

This webinar will lay out the whole process systematically and in a simplified manner. It will help you to understand how what you do and your goals and objectives, contribute to the overall success of the company, both in terms of product approval by the FDA or in terms of successful inspection outcomes. At the end of the webinar, you will be able to have better communication with your functional colleagues and the quality and regulatory affairs departments. This will lead to higher quality product, easier approvals, many fewer errors and much less friction between departments. It is a must for anyone that is either joining the Pharmaceutical / Biotechnology / Medical Device industries for the first time, or anyone that is transferring from one part of the company to another part (e.g. from discovery to development and vice versa). Also for international attendees that need to familiarize themselves with the FDA process and how it differs from other regulatory authorities.

Areas Covered in the Session :

Stages of Drug Development and Review

Drug Review Steps Simplified

Reviewing Applications

Accelerated Approvals

Bumps in the Road

The Role of User Fees

The Quality of Clinical Trials

How Drugs are Approved

How does the FDA differ from other regulatory authorities

Frequently Asked Questions about the FDA Drug Approval Process

Who Will Benefit:

This is a fundamental course that will benefit the following people:

Anyone that works or plans to work in Pharmaceutical, Biotechnology or Medical Device Industries will benefit.

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1398