The number and complexity of regulatory documents has increased significantly in the last decade as the volume of clinical trials and the regulatory burden have grown. The expedited clinical research for Covid -19 vaccines and therapeutics has further demonstrated the need for rapidly generating high quality regulatory documents to ensure patient safety [...]
Plain language summaries (PLSs) aim to meet a need in the industry for clinical trial transparency in a way that is meaningful and understandable for patients and the general public. As the pharmaceutical industry steps up to meet this requirement, patient panels play a crucial role in ensuring that information shared by sponsors [...]
Conferences and Workshop Presentations Creating Meaningful Phase 1 PK Lay Summaries Speaker: Vidhi Vashisht CBI Lay Summary Summit, Sep 2018 General Data Protection Rule: What is in for Redaction and Anonymization Speakers: Pooja Phogat and Shalini Dwivedi DIA Medical Writing India Chapter, Aug 2018 CBI Clinical [...]
Join this free webinar to learn how the pharmaceutical industry is engaging with patients and patient advocates to gain feedback and produce high-quality plain language summaries. When Friday December 06th 9 am EST | 2pm GMT | 3pm CET | Register
Reserve your place at our webinar to learn about Health Canada PRCI requirements, differences with EMA policy 0070 and how to bring synergies between the two regulatory requirements.
Reserve a place on our webinar to explore the current state of regulatory technology and how it isn't fit for the challenges of regulatory lifecycle management and new regulatory operating models.
Reserve your place on this joint webinar with Nividous regarding RPA in life sciences. We will talk about use cases and benefits of automation in healthcare and life sciences industry.
On June 20th and 21st 2018, Kinapse is sponsoring the CBI's 7th annual Publication and Clinical Trial Transparency conference in Amsterdam.