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Format for Making Regulatory Submissions to Ensure a Quicker Approval Webinar  

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Seminar Summary:

Learn to organize new drug applications ;NDAs abbreviated new drug applications ;ANDAs and biological license applications;BLAs for FDA submission. (see full course description)

 

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Training Course Syllabus:


Format for Making Regulatory Submissions to Ensure a Quicker Approval Webinar

Time: 11:30 AM PST, 02:30 PM EST

Duration: 90 Minutes

Instructor: Barry Zalma


Description:

This webinar highlights the procedures necessary to protect a defendant who has been sued for tort damages that can be insured by a liability insurance policy. Every professional business person recognizes that the business, its officers or employees will, at some time, be sued.


Why Should you Attend

Almost every business will, at some time in its existence, be sued. The suits may be false and fraudulent, a suit where there is a possibility you will be found liable to the plaintiff or a suit where you owe no liability to anyone. Every insurer will face a suit for breach of contract or for causing damage to another person or entity as a result of negligent or intentional conduct. Every business, therefore, needs a proactive effort at risk management to avoid or limit litigation against it.

As contingent or unknown losses cannot be predicted by an individual business, it must manage the risk of loss by contingent events that will bring about suits seeking tort damages.

This program explains that risk management is the process of identification, analysis and either acceptance or mitigation of uncertainty in business. Essentially, risk management occurs anytime a business analyzes and attempts to quantify the potential for losses in business. It explains how to deal with a lawsuit that is filed naming the business as a defendant, including how to obtain insurance before the suit and how to deal with your insurer after suit is filed.

If the business is sued for a tort or breach of contract not insured the program will advise how to retain and control the work of defense counsel and explain the reason why to settle or not settle a lawsuit.


Objectives of the Presentation:


  • How to acquire a policy to protect against risk of loss

  • How to present a claim to an insurance company

  • How to gather the evidence necessary to assist the insurer and the appointed defense counsel in the obligation to defend the company

  • How to prove the amount of loss

  • How to deal with the insurer´s representative

  • How to understand the methods of dealing with an insurance company after a claim or suit is made against the business

  • How to identify each coverage available to your business to protect against tort actions

  • How to identify a simple claim where suit is filed against the business

  • Discover how insurers negotiate with tortfeasors

  • Discover how to manage your attorneys




Seminar Summary:

Learn to organize new drug applications ;NDAs abbreviated new drug applications ;ANDAs and biological license applications;BLAs for FDA submission. (see full course description)

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