Date: | August 3, 2017 - 9:00am - August 4, 2017 - 6:00pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States, Raleigh, NC, NC, 27560, United States |
Website for Event: | http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901036SE... |
Topic: | Personal Trainers and Personal Training |
Description: | Course "FDA Legal Writing Skills that Result in Effective Regulatory & Quality Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA. The success or failure of many new drugs, biologic or medical device projects hinge on presenting essential information in a persuasive manner. Do you use these legal drafting skills when preparing quality and regulatory documents?In this seminar, you will learn the legal writing skills and practical techniques that will enhance your chances for success even if some of your test results or other supporting information are somewhat lacking. Remember, good regulatory writing will meet FDA branch-level requirements but the best and most effective submissions can withstand scrutiny at the FDA Division level. Why you should attend: Most regulatory, quality and R&D professionals rise within an organization due to their scientific and technical understanding of the products in their company's pipeline. However, those professionals who can prepare written and oral arguments that effectively persuade regulatory agencies to agree with their positions are the one who achieve the highest levels of success within the organization. Lawyers know these writing techniques - do you? Areas Covered in the Session: • Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations. Who Will Benefit: The seminar will be valuable to any person working in Regulatory Affairs or Quality Management who is responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products. Agenda: Day 1 Schedule Lecture 1: Lecture 2: Lecture 3: Lecture 4: SpeakerRobert J Michalik Robert J Michalik, J.D.., RAC, is a Massachusetts regulatory attorney and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries.Mr. Michalik has over 25 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. For more than 10 years Mr. Michalik was an Adjunct faculty member with Northeastern University (Boston, MA) Master's Program in FDA Regulatory Affairs. Location: Raleigh, NC Date: August 3rd & 4th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States Price: Register now and save $200. (Early Bird) Contact us today! Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=...
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Contact Name: | Event Manager |
Contact Email: | john.robinson@globalcompliancepanel.com |
Contact Phone: | 800-447-9407 |