Whitsell Innovations, Inc. presents Common Technical Document workshop for Brazilian pharmaceutical organization Sindusfarma
Posted on July 2, 2021 in News
FOR IMMEDIATE RELEASE:
Chapel Hill, NC – July 2021 – Whitsell Innovations, Inc. presents Common Technical Document workshop for Brazilian pharmaceutical organization, Sindusfarma.
Whitsell Innovations (WI), Inc., is pleased to announce that Robin Whitsell, Founder and President, presented a 3-day workshop on the Common Technical Documents (CTD) entitled “CTD M2 – How to write clinical and non-clinical summary documents” to a group of over 75 Brazilian pharmaceutical professionals.
Ms. Whitsell presented the workshop virtually from June 23 to June 25, 2021. The main objective was to familiarize attendees with the CTD format. Ms. Whitsell presented a series of presentations on the following:
- Introduction to ICH and CTD
- Planning a submission: what to do before starting to write, interdependence between CTD sections and package inserts
- Introduction and best practices for authoring and reviewing processes
- Introduction to nonclinical summary writing
- Introduction to clinical summary writing
- Best practices for developing clinical documentation
The workshop was hosted by Sindusfarma, a Brazilian pharmaceutical products industry union that consists of companies that produce around 80 percent of all medicines marketed in Brazil. ANVISA, Brazil’s regulatory agency, became a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2016 with a commitment to adopt the ICH guidelines including the CTD structure by November 2021. Sindusfarma develops and provides educational programs to help train the Brazilian pharmaceutical workforce to achieve this goal in collaboration with industry experts like WI.
“I am delighted and honored to support Sindusfarma as Brazil is making this transition into adoption of the ICH guidelines and use of the CTD,” says Ms. Whitsell. “This transition positions Brazilian companies to share their innovations with global markets.”
ABOUT WHITSELL INNOVATIONS, INC.
WI is a Women’s Business Enterprise National Council (WBENC)-certified, woman-owned, full-service medical and scientific writing company headquartered in Chapel Hill, North Carolina.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties, and other factors not under the company’s control. Whitsell Innovations, Inc.’s actual results, performance, or achievements could be materially different from those projected by these forward-looking statements. Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.