Webinar on Writing Skills for Regulatory Attorneys
Robert J Michalik, Esq., founder of RegulatoryPro.com, “a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries,” will be hosting a Webinar on writing skills for regulatory attorneys.
From the announcement:
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.
