As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.
With such abundant clinical trial opportunities in China, and such a wide range of innovative eClinical technology available to take advantage of them, there has never been a better time to be a clinical researcher.
Recently, nearly 2000 participants attended the 10th Annual Scope Meeting. Read the expert perspectives, insights gained from lessons learned and forward-looking predictions across 10 parallel tracks focused on functional areas and emerging disciplines within clinical development.
Recent scandals surrounding Chinese drug manufacturers have Chinese nationals looking outward, and have even sparked regulatory reforms. This lost faith in local drug companies begs the question: what does this mean for foreign investors?
Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.
With buzzwords such as patient centricity, patient experience and health literacy rapidly becoming the new reality, executives from TrialScope share their predictions for the coming year.
Software implementation does not have to be a scary proposition. In this video, implementation experts – with a 100% success rate – discusses what works and why.
Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors? This webinar explores both Right-to-Try legislation and existing Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.
This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development
How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program.
Marketing application submissions, including NDAs, biologics license applications (BLAs), and premarket approvals (PMAs) in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you navigate submissions in the most efficient and effective way.
This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.
Download the at a Glance Schedule for DIA 2019 Global Annual Meeting - San Diego - June 23-27.
What's happening at DIA in 2019? Download the DIA Events and Training Calendar to see where and when DIA will be hosting conferences, meetings, short courses, and training opportunities for you and your team.
When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.