Pharma Tutor

JULY 18, 2022

This has also resulted into stricter norms for Marketing Authorization (MA) and Good Manufacturing Practices (GMPs). Mon, 07/18/2022 - 15:31. Read more about Drug Regulatory Affairs Certificate Institutes in India Log in or register to post comments

Drugs 59

Drugs Manufacturing Vaccination Vaccine 59

Rethinking Clinical Trials

FEBRUARY 16, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Wendler, PhD, MA; Miguel Vazquez, MD; P. Opt-outs were different across health systems. Pearl O’Rourke, MD; David S. Michael Ho, MD, PhD) appeared first on Rethinking Clinical Trials.

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Clinical Trials Clinical Trials Medicine Trials 130

Pharmaceutical Technology

JULY 14, 2022

Due to the high price tags associated with these speciality medicines, innovators have naturally favoured big markets with high GDP such as the US and EU-5 (Germany, France, Spain, Italy, and the UK). “The Go-to-market strategies. The choice of where to launch an orphan drug is an important and difficult decision.

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Drugs Medicine Marketing Development 147

Rethinking Clinical Trials

APRIL 27, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc) appeared first on Rethinking Clinical Trials.

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Trials Clinical Trials Clinical Trials Medicine 130

pharmaphorum

SEPTEMBER 30, 2022

The process starts adding fields to regulatory submission templates that will incorporate re-used information, then building templates with standardized structures and including structured data tags and sources. Fillable metadata is next added to the templates. He is a strong proponent of standards and data governance.

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Compliance Life Science Marketing Production 52