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Technical and Regulatory Writing for FDA Regulated Industries

By:
Dr. Mukesh Kumar, PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research
Coming soon.. Please contact customer care for new schedule

Course Description:

Regulatory professionals have to write highly technical documents for a wide audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents spanning everything from simple issues, such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators.

Some of the key takeaways from this seminar will include:

  • Practical tips using examples on how to organize and deliver information in clear and readable documents.
  • How to edit, format, present and publish technical regulatory documents for most favorable reception by regulatory agencies.
  • Rules for writing documents intended for electronic submission to regulatory agencies.
  • Technical, practical, logical and logistical tips for all regulatory writers.


Who will Benefit:

  • Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
  • Medical and technical writers
  • Project managers and directors
  • Supervisors and lead workers in regulatory affairs
  • Quality assurance and quality control
  • IT professionals looking to make eCTD submissions

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar





Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 3:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • 9:00 – 10:30 AM: Lecture 1: Expectations from Regulatory Documents
    • Relationship between technical and regulatory writing
    • Documents required as per regulations in the US and EMA
    • Modular and full-scale writing practices
    • Resources needed for writers
    • Scope of writing versus creating data elements
  • 10:30 – 10:45 AM: Break
  • 10:45 – 12:30 noon: Lecture 2: Ground Rules for Writing, Formatting and Updating Content
    • Formatting and version control for content intended for electronic submission
    • Using MS Office elements to create e-ready documents
    • Hyperlinks and cross-links in an XML environment
    • Best practices for MS Word and Adobe PDF in an eCTD environment
    • Best practices for styles in all regulatory documents
  • 12:30 – 01:15 PM: Lunch
  • 01:15 – 2:45 PM: Lecture 3: Templates and Style Guides
    • Using templates for regulatory documents
    • Individualized and corporate elements in documents
    • Regulatory requirements in documents
    • Best practices for printable and electronically available documents
    • Using tables, figures, cartoons, flow charts, and other tools to drive a point
  • 2:45 – 3:00 PM: Break
  • 3:00 – 4:30 PM: Lecture 4: Writing for the Audience
    • Writing for the reader: technical appropriateness
    • Granularity requirements
    • Controlling the language and expressions
    • Best practices for evidence based writing: using references and citations
    • Organizing a document and a complete submission
  • 8:30 – 10:00 AM: Quality Control of Documents
    • English as the first, second or third language
    • Non-English writing styles: role of cultural sensitivity in writing
    • Rules for copy editing and content editing
    • Project management for documentation: regulatory requirements
    • Tracking changes: attribution, creating clean and red-lined documents
  • 10:00 – 10:15 AM: Break
  • 10:15 – 12:00 noon: Common Regulatory Documents
    • SOPs
    • Clinical protocols and study reports
    • Correspondence: emails, meeting minutes, and notes to file
    • Integrated summaries and reviews of literature
    • Rules for multi-dimensional documents: complete regulatory submission
  • 12:00 – 12:45 PM: Lunch
  • 12:45 – 2:15 PM: Common Technical Documents
    • Manuscripts for peer reviewed publications
    • Informed consent forms
    • Strategy documents
    • Lab notebooks and other laboratory documents
    • Marketing and sales training documents
  • 2:15 – 2:30 PM: Break
  • 2:30 – 3:30 PM: Attributes of a Skilled Regulatory Writer
    • Researching background material
    • Regulatory intelligence
    • Gap analysis and strategy reports
    • Training technical writers in regulatory writing
    • Matrices for evaluating writing skills





Meet Your Instructor:

Dr. Mukesh Kumar
PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about more than 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker in several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.






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