Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

Why Should You Attend:

Attorneys learn how to present information in a manner most beneficial to their clients. Regulatory attorneys use these same skills to enhance the persuasiveness of submissions destined to regulatory authorities in the U.S. and worldwide. The success or failure of many new drugs, biologic or medical device projects hinges on presenting essential information in a manner that is most persuasive to a regulatory reviewer. Do you use these skills when drafting quality and regulatory documents?

As every Product Development Manager knows, even the best programs are hampered by deficiencies or gaps in data that exist at the time of reporting or submitting data to an Agency (e.g., FDA, EU EMEA, EU Notified Body). The key skill is knowing how to present required information in a way that will increase, not jeopardize the likelihood of timely project success. Fortunately there is an array of proven legal and technical writing techniques and strategies exist to help guide you and the team to success. Do you know them?

In this webinar, you will learn the writing skills that will enhance your chances for success even if some of your test results or other supporting information are somewhat lacking. The quality and regulatory professional must know how to structure a written argument that highlight “good” data while also diminishing the negative impact due to data gaps or deficiencies.

Areas Covered in the Webinar:

• Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations.
• Step-by-step analysis of how to present both good and poor data in a persuasive manner.
• How to train scientists and engineers to generate "good" data to support legal, regulatory and quality claims?
• Tips and secrets to framing an argument that makes even poor data look good.
• Examples of good writing that can be useful templates for training and skills development.
• What you should never say in a quality or regulatory document?

Who Will Benefit:

The Webinar will be valuable to any person working in Regulatory Affairs or Quality Management who are responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products.

• Regulatory Affairs professionals
• Quality Assurance professionals
• Marketing professionals
• Middle-to-senior management of Engineering / Product Development
• Consultants

Instructor Profile:

Robert J Michalik, Esq., RAC, is a licensed attorney in Massachusetts and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. Mr. Michalik has over 20 years experience working in the biopharmaceutical and medical device industries. Starting with a bachelor’s degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities. In addition to his legal and regulatory practice, Mr. Michalik is also a faculty member at Northeastern University in Boston, MA where he teaches graduate-level coursework in the areas of FDA law and regulation within the Masters Degree in Regulatory Affairs program.

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