Insights by APCER Life Sciences

Insights by APCER Life Sciences

Point of view on the aspects of drug safety, regulations and quality assurance.

COVID-19 vaccine strategies: Are we immune to emerging variants? - APCER Life Sciences 10/06/2021

Know more about the geographical emergence of the SARS-CoV-2 variants and its impact on the global vaccine strategies: http://bit.ly/apcer_vsev

COVID-19 vaccine strategies: Are we immune to emerging variants? - APCER Life Sciences As the global vaccination drive had started breaking the chain of spread of the disease, the emergence of viral variants surfaced a new challenge. These mutated viral strains have been found to be targeted by some of the existing vaccines, though with a lesser efficacy as compared to the classical S...

Regulatory considerations for cellular and gene therapy products in EU and US: A comparative analysis - APCER Life Sciences 10/06/2021

Do you know that EMA and FDA are encouraging expedited approvals for cell and gene therapy products? Click to learn more: http://bit.ly/rcfcandgtp

Regulatory considerations for cellular and gene therapy products in EU and US: A comparative analysis - APCER Life Sciences The cell and gene therapy products are being developed at a very fast pace with …

COVID-19 vaccine strategies: Are we immune to emerging variants? - APCER Life Sciences 10/06/2021

As the efforts to vaccinate maximum possible people globally has increased, there is a growing focus on the safety and efficacy of the vaccines especially with the emergence of mutated variants of the virus. Download to learn more: http://bit.ly/apcer_vsev

COVID-19 vaccine strategies: Are we immune to emerging variants? - APCER Life Sciences As the global vaccination drive had started breaking the chain of spread of the disease, the emergence of viral variants surfaced a new challenge. These mutated viral strains have been found to be targeted by some of the existing vaccines, though with a lesser efficacy as compared to the classical S...

Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry - APCER Life Sciences 10/06/2021

How are cell and gene therapy products classified and regulated in the EU and US? Click here to read more: http://bit.ly/APCER-cgt-classification

Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry - APCER Life Sciences Advanced therapy medicinal products (ATMPs)/cellular therapy and gene therapy (CGT) products are a rapidly growing innovative class of biopharmaceuticals due to their potential to offer therapeutic breakthroughs for many ailments, especially life-threatening cancers and rare serious inherited disord...

Pragmatic approaches to risk minimization measures - APCER Life Sciences 10/06/2021

Are you a registration holder of complex products like vaccines, combination products, biologics and biosimilars? Learn how to plan risk minimization measures in advance to achieve compliance: https://bit.ly/patormm1

Pragmatic approaches to risk minimization measures - APCER Life Sciences Every therapeutic modality has associated risks. These risks, if not managed well, can pose threat to patient safety or even public health and regulators take this very seriously.

ATMPs - Breakthrough Treatments for Rare Diseases and Patient Management 10/06/2021

Dr. Vineet Kacker, MD & Global Technical Head talks about how Advanced Therapy Medicinal Products (ATMPs) are enabling breakthrough treatments for rare diseases and entailing patient management. Click here to view the complete video: https://bit.ly/atmps12

ATMPs - Breakthrough Treatments for Rare Diseases and Patient Management In this short video, Dr. Vineet Kacker, Managing Director & Global Technical Head talks about the factors contributing to growth of Advanced Therapy Medicina...

COVID-19 vaccine strategies: Are we immune to emerging variants? - APCER Life Sciences 10/06/2021

Download our latest article to learn how the research community is trying to keep pace with the variant strains and how this has impacted the vaccination strategy: http://bit.ly/apcer_vsev

COVID-19 vaccine strategies: Are we immune to emerging variants? - APCER Life Sciences As the global vaccination drive had started breaking the chain of spread of the disease, the emergence of viral variants surfaced a new challenge. These mutated viral strains have been found to be targeted by some of the existing vaccines, though with a lesser efficacy as compared to the classical S...

Accelerating product approval by handling complex and voluminous medical writing projects - APCER Life Sciences 10/06/2021

We enabled a global Life Sciences company file for earlier approval by handling complex and large volumes of e-submission-ready documents in a short duration of time. Click here to read more: http://bit.ly/apcer_apahc

Accelerating product approval by handling complex and voluminous medical writing projects - APCER Life Sciences Our Medical Writing team helped the client in handling e-submission ready documents and accelerated the …

Regulatory considerations for cellular and gene therapy products in EU and US: A comparative analysis - APCER Life Sciences 10/06/2021

Are you aware of the applicable regulations and legislations for ATMPs/CGTs in the US and EU? Click to learn more: http://bit.ly/rcfcandgtp

Regulatory considerations for cellular and gene therapy products in EU and US: A comparative analysis - APCER Life Sciences The cell and gene therapy products are being developed at a very fast pace with …

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