FDA Effective Regulatory & Quality Submissions 2017

FDA Effective Regulatory & Quality Submissions 2017
Event on 2017-08-03 09:00:00
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.


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.
• 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 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.
• Regulatory Affairs professionals
• Quality Assurance professionals
• Marketing professionals
• Scientific and Engineering / Product Development Managers
• Consultants to any regulated industry


Day 1 Schedule

Lecture 1:
• Day 1: Brief Introduction to Seminar Topics
o Summary of Day 1 Agenda – Training Objectives, Processes and Deliverables
• Regulatory Affairs & Administrative Law: Public Policy & Legal Objectives
• Hallmarks of Effective Legal Representation: Serving the Public while Meeting Client Needs
• Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives – A Practical Summary
• Day 2: Legal Writing Skills Development: Best Practices
o Summary of Day 2 Agenda – Training Objectives, Processes and Deliverables
• Legal Writing in Quality System Development; Policies, SOPs and Reports; Responses to FDA 483 Inspectional Observations
• Legal Writing in Premarket Product Development; Design Control & Quality-by-Design (Q-b-D); Drug & Biologic IND, medical device IDE and FD&C Act § 510(k)
• Legal Writing in Postmarket Product Development; New Drug Applications, Biologic License Applications, Premarket Approval Applications; Postmarketing Changes (CBE-30, PAS)
• Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives – A Practical Summary

Lecture 2:
• Step 1 to Persuasive Legal Writing: Understand the Basic Principles
• Introduction to Administrative Law & Legal Argumentation
o Legal Principles 101 and Applicability to Regulatory Compliance
o Legal Writing: Theory and Practice
o How to Address & Resolve Issues in Contention
 IRAC – Issues, Rules, Analyses & Conclusions
o Agencies are bound by Rules; Learning to Work within FDA Restrictions

Lecture 3:
• Hallmarks of Effective Legal Representation: Serving the Public while Meeting Client Needs
• Finding applicable law: Acquiring "Arrows in your Quiver"; Data and decisions that support your legal argument.
o Statutory law, regulatory requirements, relevant case law, agency rulings, Guidance for Industry, and Industry consensus standards

Lecture 4:
• Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives – A Practical Summary
o Break out Sessions – Applying Legal Writing Principles to Meet Regulatory Objectives
 Case studies assigned to groups;
 Draft IRAC responses to persuasively address issues

Robert 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


Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
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Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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at Courtyard Raleigh-Durham Airport
2001 Hospitality Ct, Morrisville, NC 27560, United States
Morrisville, United States

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