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 Theresa Shalaby, MSN, RN Engaging the patient is key to support clinical trial recruitment and have truly patient-centric drug development. Writing for patients and the general public is vastly different from writing for regulatory authorities or clinicians. Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and … 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
Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. However, this is a challenging process for today’s complex drugs and alternative delivery methods. Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The … Continued
