By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics. Health Canada implements eCTD for Clinical Trial Applications Health Canada accepts electronic Common Technical Document (eCTD) … Continued
By Yuancheng Chen, Research Associate of Phase 1 Unit, Huashan Hospital, Fudan University, and visiting scholar of Uppsala University Certara recently held its first virtual Phoenix User Group meeting in China. Over this three-day meeting, attendees learned from Certara’s experts on specific Phoenix workflow examples, updates to the Phoenix product roadmap, an overview the latest … Continued
3 key tips to set your pediatric program up for success with the RACE for Children Act by Lynne Georgopoulos, RN, MSHS, RAC, Vice President, Regulatory Strategy at Certara On 2020年8月18日, the Research to Accelerate Cures and Equity (RACE), which amends the Pediatric Research and Equity Act (PREA) comes into effect. With the … Continued
This blog asks and answers 10 critical drug development questions whether you have a new molecular entity or are repurposing a drug already in clinical use.
Henri Merdjan explains why topical drug formulations (e.g. intranasal and/or oral) could be valuable as a therapeutic option for COVID-19 patients.
This blog discusses how decision analysis approaches can help drug developers to better decisions under multiple criteria and uncertainty.
Introducing our three-part blog series on getting started with in-house development. In this series, we’re detailing some key aspects of how you can create and deploy your own mobile apps, for the purposes of stakeholder engagement and value communication, in-house—without the help of external agencies. Developing mobile apps in-house is increasingly popular compared to outsourced … Continued
Introducing our three-part blog series on getting started with in-house development. In this series, we’re detailing some key aspects of how you can create and deploy your own mobile apps, for the purposes of stakeholder engagement and value communication, in-house—without the help of external agencies. Developing mobile apps in-house is increasingly popular compared to outsourced … Continued
Model-based Meta-analysis is a framework to compare drugs used to treat diabetic peripheral neuropathy, post-herpetic neuralgia & fibromyalgia.
Nirpal Virdee, Synchrogenix’s Global Head of Transparency and Disclosure recently sat down with Trishna Bharadia, award-winning health advocate and patient engagement champion, for a discussion around patient engagement and patient centricity. Their discussion was moderated by Darshan Kulkarni of the podcast ‘Darshan Talks’ for a series of episodes that you can listen to here. Darshan … Continued
