sfp consulting, LLC

Training


SFP Consulting provides team or individual training on the scientific and drug development processes (eg, CTD or NDA process), regulatory issues (informed consent), and project-specific topics (labeling). Topics include instruction and practice in preparing all of the documents mentioned under Services, especially those in the CTD. Instruction on optimizing document review processes, writing for electronic submissions, how to review statistical analysis plans, and use of contractors for writing projects is also provided.


Note: Any topics in the sessions mentioned below can also be presented separately, possibly in an expanded form as necessary. In addition, these sessions can be tailored to the needs of a specific company to include additional topics and/or to use house templates and styles.


Current offerings include (but are not limited to) the following courses:


Preparing the Clinical Sections of a CTD/eCTD


Session 1 (2 hours):

The following topics will be presented:

• Brief CTD Overview
• The Clinical Plan
• Labeling and the Target Product Profile
• ICH Guidelines – Clinical
• Module 2.5 Clinical Overview


Session 2 (2 hours)

The following topics will be presented:

• ICH E3 – Clinical Study Report
• Module 5 Organization
• Reference Lists


Session 3 (2 hours)

The following topics will be presented:

• Module 2.7 Clinical Summary
• Integrated Summary of Safety/Integrated Summary of Efficacy


Session 4 (2 hours)

The following topics will be presented:

• IND to CTD Mapping
• Transitioning to an eIND
• Tips on Writing for Electronic Submissions
• CTD Content/Process Workshops
• Roundtable Review Meetings



Preparing a Clinical Study Report – 4 hours


The following topics will be presented:

• Using a template based on ICH E3 Guideline
• Assembling a “shell”report from the protocol and statistical analysis plan
• Writing efficacy and safety results including selection of in-text tables
• Summarizing for the discussion and synopsis
• Assembly of appendices

Includes practical exercises in writing the study design and safety sections.



Writing Safety Narratives – 2 hours


The following topics will be presented:

• Designing and using an appropriately detailed template (using various examples or the house template)
• Writing narrative text including in-text tables of laboratory, vital sign, or ECG results when necessary
• Requesting data displays for use in safety narratives (eg, dates vs durations, verbatim vs coded drug names)

Includes a practical exercise in narrative writing from listings and CIOMS/MedWatch information.



Writing Clinical Study Protocols – 1.5 to 2 hours


The following topics will be presented:

• Preparing a protocol plan
• Writing a full protocol
• Amending a protocol

Includes a practical exercise in preparing a protocol amendment.



Writing for Electronic Submissions – 1.5 to 2 hours


The following topics will be presented:

• Using authoring templates
• Using style guides/sheets
• Portable Document Format (PDF) specifications
• Hyperlinking processes
• Quality control



Managing Contract Writers for Timely Delivery of Quality Writing Services – 30 minutes


The following topics will be presented:

• Why use contractor writers?
• Setting up for success
• Document production process
• Pitfalls and tips



Innovative Roundtable Strategies Accelerate Timelines – 30 minutes to 1 hour


The following topics will be presented:

• Roundtable meetings
• What are they?
• Why have them?
• Basic roundtables
• Advanced concepts
• Practical tips



Reviewing Statistical Analysis Plans –1.5 hours to 2 hours


How to Get Displays You Can Use to Write and Quality Check Safety Data More Efficiently


The following topics will be presented:

• Reviewing statistical output for clinical study reports
• Reviewing statistical output for integrated summaries
• Using graphics: a picture is worth 1000 words
• Providing listings specifications to support safety narrative writing:



Making a Robust Guidance for the CTD Summary of Clinical Safety and Parallel ISS: Writing Manual and Development Team Planning Tool – 1 to 1.5 hours


The following topics will be presented:

• Learn how to construct a robust guidance for the CTD Summary of Clinical Safety (SCS) and ISS based on ICH M4E, additional regulatory guidances, and other available information.


Explore how to use this document as a writing guide and as a tool to lead indication-specific project team discussions on CTD Section 2.7.4.



Menu

Writing Services Consultation Training MeduMaZe