INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
Establishing A Culture Of Inspection Readiness
Inspection readiness is not simply something you do; it is a state of operation. It is optimal good clinical practice and an ongoing organizational discipline. Learn the processes that must be completed to establish a culture of inspection readiness.
Why And How Global Healthcare Product Regulators Are Joining Forces
The ICMRA is now considered a strategic cross-border leader among a select group of global medicine and device regulatory policy bodies. Read how the coalition is working across the world to help sponsors develop medical products in a more globally harmonized way moving forward.
Botanical Medicines In Research
Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.
Regulatory Oversight On Gene Therapy In The U.S. And EU
Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.
Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access
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.
Achieving The Promise Of Gene Therapy: New Pathways To Overcome Patient Enrollment And Safety Challenges
This webinar examines the evolving science of gene therapy, covering current approaches such as gene transfer and gene silencing, safety considerations, and delayed adverse events. Learn about the current regulatory landscape, identify opportunities to more closely engage with regulators, and more.
Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar
In January 2019, the US Food and Drug Administration (FDA) updated its 2015 draft guidelines for drug discovery in rare diseases. The update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of the development process. In this webinar, learn about the core elements of the new guidance plus the latest recommendations and instructions from the agency along with practical examples and applications.
What Level Of Review Does Your Study Need?
The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.
Risk Evaluation And Mitigation Strategy (REMS) Overview
UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.
CLINICAL TRIAL REGULATORY SOLUTIONS
Study Start Up
One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.
Global Multilingual Call Center
TransPerfect's device-independent call center solutions allow you to easily and affordably route calls to our global call centers where we intake and process cases, either as part of a clinical trial or in supporting post-marketing pharmacovigilance efforts (adverse events, medical information, product complaints, patient registries, etc.).
Contract Packaging Services For Clinical Trials
Ropack Pharma Solutions offers turnkey primary and secondary pharmaceutical packaging services of solid oral dosages into blisters, bottles, flip-top vials, stick-packs and sachets.
eRegulatory Buyer’s Guide
As you begin your journey to adopting an eRegulatory solution, choosing which system to adopt can seem like a daunting task. How can a first-time buyer sort through the bells and whistles to parse out what elements are truly necessary?
Pharmacovigilance System Master File
One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.