Rho Webinars
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Development Advice For Gene Therapy Products
1/29/2019
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
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Understanding Common Causes Of Failure in Depression Studies
1/28/2019
Dr. Jack Modell discusses why there is more to the story than placebo response in regards to the high failure rate of clinical studies in depression. Identify other factors that can contribute to failures and what steps can be taken to avoid those pitfalls.
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Understanding FDA’s Priority Review Voucher System
1/28/2019
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.
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Not Just Tiny Humans: Conducting Pediatric Clinical Trials
1/28/2019
While we can’t predict the outcome, planning ahead for appropriate site and subject selection will take you one step closer to ensuring the successful conduct of a study. From study design to logistics to recruitment, this webinar will look at the key differences between studies conducted in pediatric populations and studies conducted in adult populations.
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Putting Patient-Centered Principles Into Practice
1/28/2019
This webinar will explore the rationale for implementing patient-centered practices and offer guidance for initiating patient-centered approaches to research. Review practical strategies for engaging patients in the clinical trial process without sacrificing research quality or adding untenable costs to your trials and understand which factors matter to patients and how to design trials that honor their needs and desires.
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Detecting, Handling, And Reporting Data Falsification, Misconduct, And/Or Suspected Fraud
1/28/2019
Whether indications of fraud appear as missing documentation, altered numbers, signatures that don’t match, or unavailable medical records Clinical research associates (CRAs) must be aware of the many signs of possible fraud or fabricated data occurring at a clinical trial site. This webinar explains the signs to look for and the proper protocol to handle and report the misconduct during each monitoring visit.
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Understanding NDAs
1/28/2019
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.
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Small Size, Big Plans- Drug And Biologic Development Advice For Small Companies
10/17/2018
This webinar will provide advice on how to set your small company up for long-term success through the use of strategic development plans, purposeful outsourcing, patent protection, partnership strategies, and provide specific examples of success stories and lessons learned.
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Bench To Clinic: Planning For A Successful Translation
10/17/2018
This webinar will provide an overview of the clinical, nonclinical, CMC, and regulatory activities necessary for a successful IND submission.
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What To Do With Suspected Compliance Issues At A Clinical Study Site
5/5/2017
This webinar includes tips to help quality, project management, clinical, and site personnel manage conflicts as well as a review of the applicable regulations and reporting requirements.