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Blue Sky eLearn Path LMS

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  • CMC Quality (4)
  • Covid-19 (2)
  • Development (4)
  • Discovery (3)
  • Harmonization (1)
  • Immunogenicity (2)
  • Leadership Management (3)
  • Market License (4)
  • qPCR (1)
  • Vaccine (1)

Roadmapping the Clinical and Regulatory Paths of Subcutaneous Products and Technologies

  • 2

Intro to Biomarkers: Assay Validation/Qualification, Regulatory Guidance and Application

The short course will focus primarily on the discussion of technologies, key issues in assay development and some regulatory considerations of biomarkers to ensure...

  • 5

Dissolution Best Practices and International Harmonization

This workshop will cover best practices, science-based approaches, rationale of CHP requirements. We will also discuss strategies to partner with our CHP colleagues...

  • 2

Stats Snax: Bite-sized Statistical Concepts

​Stats Snax is a series of short videos (3 – 15 min) that discuss basic statistical concepts that apply to the pharmaceutical industry, using examples from CMC...

  • 8

Drug Transporters in ADME: From the Bench to the Bedside

Scientists working at every career stage and in every part of the pharmaceutical community, including academia, industry, and regulatory, will come together to discuss...

  • 1
  • 6

Patient-Centric Design of Long-Acting Injectable Drug Products

  • 4

Measurement and Understanding of Immune Response in Context of Clinical Development

This workshop covers key aspects of the assessment of immune response considerations in discovery and pre-clinical studies, from the clinical stages through approval.

  • 1
  • 2

Optimizing Extraction Recovery for Volumetric Adsorptive Microsampling (VAMS)

Compared to in-clinic sample collection, in-home sampling has many advantages. It saves time for patients, especially those who may be prohibitively far from a clinic...

  • 1

Journey of Biomarker from Discovery to Qualification

Noninvasive monitoring of nephrotoxicity is challenging. Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood urea nitrogen, and serum...

  • 1

Development and Regulatory approval for Toxicogenomics (TGX) biomarker to detect DNA damage-inducing agents

Gene expression biomarkers are now available for application in the identification of genotoxic hazards. The TGx-DDI transcriptomic biomarker can accurately...

  • 1

Covid-19 Safety Testing Approaches

Rafiq Islam, Executive Director of Bioanalysis describes the approach that Celerion has taken to ensure the safety of our employees and patients via a suite of viral...

  • 1

Mitigation Strategies for US and EU Supply Chain Risk Introduced by the COVID-19 Pandemic

The current global health crisis has a profound effect on the pharmaceutical supply chain, from raw materials, to clinical supply, to store shelves. This 30-minute...

  • 1

Is Your Lab Cloud Ready

Originally driven by IT needs, cloud technology adoption is now being led by far reaching business demands.

  • 1

Computational Studies of SARS-CoV-2 Application of Computational Chemistry and A.I.

The rapid outbreak of the novel severe acute respiratory syndrome 2 (SARS-CoV-2) has reached pandemic level and poses a serious global public health concern. Since the...

  • 1

What We Need to Learn from Failures in COVID-19 Testing

The COVID-19 pandemic has not only disrupted our lives on all fronts, but it has also exposed our need to focus on the highest quality and safety in testing. With...

  • 1
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