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Tag: regulations

Consulting

How to Navigate Global Regulatory Frameworks & Expedited Programs for Gene Therapy Development in the U.S., EU, & Japan

As scientific knowledge, clinical experience, and acceptance of gene therapy products have evolved, so have the regulatory frameworks for ensuring the safety of these novel treatments. To date, there is no harmonized international standard for regulating gene therapy products; however, the U.S., EU, and Japan have established regulatory frameworks with subtle variations. Understanding how gene...

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Clinical Research: Phase 1 - Phase 4

Choose the Right FDA Program to Expedite Your Rare Oncology Trial

Rare cancers account for 27 percent of all new cancer diagnoses in the U.S. and 22 percent of all new cancer diagnoses in the EU.1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment...

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Clinical Research: Phase 1 - Phase 4

Drug and Device Development Secrets in the World of Medical Aesthetics

New treatment options for aesthetic indications are in record-high demand, fueled by an aging population, and a growing focus on aesthetic issues related to nutritional habits, sedentary lifestyles, the complex stresses of 21st-century life and rising awareness about aesthetic solutions in all adult age groups. The search for more effective, less invasive, more affordable and safer solutions...

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Consulting

Beware of Underestimating the Value of a Pre-NDA Meeting

Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission of...

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Clinical Research: Phase 1 - Phase 4

Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design

Competition for patients among sponsors in the field of dermatology drug development has never been as intense as it is now — so much so that it’s becoming difficult to meet project timelines, attract and retain patients, and achieve comprehensive study results. Patients are in high demand, and making studies appealing to them — convenient,...

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Consulting

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief background...

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Consulting

Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development

Professionals focused on drug development are charged with making the most of their resources, maximizing the value of their work, and bringing effective products to market as quickly as they can without compromising quality or safety. It is a long list of responsibilities, and development professionals struggle to balance all of them. Sameena Sharif, senior...

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Consulting

Real-World Data and the FDA: How to Make Sure Your Data Counts

Stacy Weil, Vice President, Clinical Data Operations, Strategic Business Optimization, and Kristi Miller, Ph.D., Vice President, Regulatory Affairs, address the following: Expanded patient enrollment options when using RWDNew strategies for collecting and monitoring patient dataRecent regulatory reforms concerning acceptance of RWDCase studies illustrating the use of RWD for regulatory purposes What’s challenging you today? Fill...

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Clinical Research: Phase 1 - Phase 4

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

Explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical...

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Medical and Regulatory Affairs

Europe’s New Trial Regulations: Quality VP to Address 2016 West and Wales Forum

DURHAM, N.C., April 05, 2016 – New European Union standards governing clinical research have significant implications for future drug trials. Nicky Dodsworth, Vice President, Quality Assurance, Risk & Compliance at Premier Research, will discuss these changes at the 2016 West and Wales Regional Forum on Innovation and Risk, April 21 in Milton Park, Oxfordshire, U.K. In...

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