On-Demand Webinar Archives

On-Demand Webinar

Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to…

CertaraNovember 19, 2021

On-Demand Webinar

External Control Arms – The Case for a Standardized Lexicon and Toolkit

Both the FDA and EMA have made statements that support the concept of using real…

CertaraOctober 12, 2021

On-Demand Webinar

Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2…

CertaraOctober 7, 2021

On-Demand Webinar

FDA’s Digital Transformation: The Future of Technology and How to Prepare

As Life-Science manufacturers embrace new technologies to speed time to market and products become more…

CertaraOctober 5, 2021

On-Demand Webinar

The Scary Future of Rare Disease Management

In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…

CertaraSeptember 23, 2021

On-Demand Webinar

Preparing Vaccine Studies for Regulatory Submissions

In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…

CertaraSeptember 10, 2021

On-Demand Webinar

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…

CertaraSeptember 10, 2021

On-Demand Webinar

What does the Clinical Pharmacology Plan for a Biologic Look Like?

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…

CertaraAugust 6, 2021

On-Demand Webinar

PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics,…

CertaraJuly 26, 2021

On-Demand Webinar

Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate

The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…

CertaraJuly 15, 2021

On-Demand Webinar

Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

External Control Arms – The Case for a Standardized Lexicon and Toolkit

Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

FDA’s Digital Transformation: The Future of Technology and How to Prepare

The Scary Future of Rare Disease Management

Preparing Vaccine Studies for Regulatory Submissions

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

What does the Clinical Pharmacology Plan for a Biologic Look Like?

PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate

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