Scientific methods for treating diseases and conditions, and the regulatory oversight over them have been growing by leaps and bounds over the past few years. Gene editing via CRISPR and nuclease enzymes such as Cas9, Cpf1 or C2c1, PAM-dependent target recognition, and gene delivery approaches such as adeno associated virus (AAV) and advancements in chimeric antigen receptor (CAR) conjugated T-cell therapies specific to an array of disease-related ligands associated with cancer are some of the hot topics of R and D today.
A fact that is true almost everywhere in the world is that legal and regulatory requirements and practices have not kept pace with the technological advancements. As a result, it is often the regulatory agency, rather than the company manufacturing products in these areas, that is responsible for delaying the release of these high-level products into the market.
One method by which organizations in these areas can mitigate this situation is to help the regulatory agency understand the submission for approval better by preparing documents that are lucid and easy to understand. This writing skill is a habit that needs to be ingrained in science professionals who make the submissions to the FDA and other regulatory agencies in the world.
Understanding of the ways of preparing well-written documentation
A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show the proper and correct method of preparing documentation for advanced legal writing methodologies for successful FDA ‘Breakthrough Therapy’ Submissions.
Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com, will be the expert of this very valuable webinar session on Advanced Legal Writing Methodologies for Successful FDA ‘Breakthrough Therapy’ Submissions. Please enroll for this highly valuable webinar by visiting http://bit.ly/2LqRE0A
Adapting new strategies
Proper and well-organized documentation for advanced legal writing methodologies for successful FDA ‘Breakthrough Therapy’ Submissions must show how the new product has taken steps for mitigating health risks. The documents submitted for approval should have clarity, and there should be solid quality and quantity of data needed to support investigational and new drug or biologic safety and efficacy claims. When these are lacking, it leads to improper regulatory submissions that lead to project delays, particularly for those in the gene therapy, cell therapy and combination product space.
R&D product manager, quality assurance, regulatory management and clinical professionals who rely on past submission strategies cannot expect to ensure authorization from FDA to proceed. They need to keep updating and sharpening their legal and regulatory writing skills and approaches to meet the challenges.
Most attorneys are taught at law schools to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. The persuasiveness of these presentations goes a long way in determining the regulatory success or failure of many breakthrough therapies.
This webinar will equip professionals involved in preparing documentation for advanced legal writing methodologies for successful FDA ‘Breakthrough Therapy’ Submissions, such as Gene Therapy /Gene Editing R&D Scientists, Regulatory Affairs Professionals, Quality Assurance Professionals, Marketing Professionals, and Scientific and Engineering /Product Development Managers with the legal drafting skills when preparing quality and regulatory documents.
Using writing to enhance chances of regulatory approval
Robert will help them ingrain the legal writing skills and practical techniques that will enhance the chances for success. While good regulatory writing meet FDA branch-level requirements; only the best and most effective submissions can withstand scrutiny at higher levels such as the FDA Division level.
At this webinar, Michalik will cover the following areas:
- 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.