Technical and Regulatory Writing for FDA-Regulated Industry
Date: April 10-11, 2025
Duration: 2 Days
Time: Starts at 10 AM EST
In the field of regulatory affairs, professionals often encounter the task of writing complex documents for diverse audiences. These documents encompass a wide range, including reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and various communication documents.
The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.
During the workshop, the trainer Dr. Mukesh Kumar will share practical tips and utilize examples to demonstrate effective methods of organizing and conveying information in clear and readable documents. They will cover essential aspects such as editing, formatting, presenting, and publishing technical regulatory documents to ensure they are well-received by regulatory agencies. Additionally, the workshop will explore the guidelines for writing documents intended for electronic submission to FDA and other regulatory authorities. This unique workshop is designed to equip regulatory writers of all skill levels with technical, practical, logical, and logistical tips to enhance their abilities.
The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.
During the workshop, the trainer Dr. Mukesh Kumar will share practical tips and utilize examples to demonstrate effective methods of organizing and conveying information in clear and readable documents. They will cover essential aspects such as editing, formatting, presenting, and publishing technical regulatory documents to ensure they are well-received by regulatory agencies. Additionally, the workshop will explore the guidelines for writing documents intended for electronic submission to FDA and other regulatory authorities. This unique workshop is designed to equip regulatory writers of all skill levels with technical, practical, logical, and logistical tips to enhance their abilities.
Who Will Benefit:
- Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
- Medical and Technical writers
- Project Managers, Directors
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control
- IT professionals looking to make eCTD submissions
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Day One (10:00 AM - 3:30 PM EST)
10:00 AM – 12:00 PM: Lecture 1: Expectations from Regulatory Documents
- Relationship between technical and regulatory writing
- Documents required by regulations in the US and EMA
- Modular and full-scale writing practices
- Resources needed for writers
- Scope of writing versus creating data elements
12:00 PM – 12:30 PM: Break
12:30 – 2:00 PM: 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
2:00 – 3:00 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
3:00 – 3:15 PM: Break
3:15 – 4:00 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
Day Two (10:00 PM - 4.00 PM EST)
10:00 AM – 12:00 PM: Lecture 5: 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
12:00 – 12:30 PM: Break
12:30 – 2:00 PM: Lecture 6: 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
2:00 – 3.00 PM: Lecture 7: Common Technical Documents
- Manuscripts for peer-reviewed publications
- Informed consent forms
- Strategy documents
- Lab notebooks and other laboratory documents
- Marketing and sales training documents
3:00 – 3:15 PM: Break
3:00 – 4:00 PM: Lecture 8: 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
Register Online (By clicking on the links below)
Prices are in US Dollars.
The registration fee includes the workshop and all related course materials.
Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com
Payment:
We accept credit card, debit card, and PayPal.
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.
