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The Endpoint Selection: a Complex Process in the Clinical Trials Design

Clinical trial outcomes selected for evaluation must address trial objectives, irrespective of their association with the interventions. Endpoints are specific measures of these outcomes and their selection is a complex process.

Pharmacometric modelling and simulation: an important tool in therapeutic decision-making

Pharmacometric PK/PD modelling and simulation are a powerful tool in therapeutic drug development decision-making

The Emergency Response to the COVID-19 Pandemic and Its effect on Clinical Trials Regulations

When COVID-19 emerged clinical trials were given guidelines not set in stone in nation-wide regulatory changes for times of natural disasters.

REGULATORY AFFAIRS FOR MEDICAL DEVICES

RA staff ensure compliance with applicable regulations, clinical trials, regulatory submissions, production, marketing, distribution & post-market surveillance

WHO launches the SOLIDARITY study, a global mega trial on the 4 most promising coronavirus treatments

WHO and INSERM launch clinical trials on the 4 most promising coronavirus treatments

First-in-humans clinical trials of vaccines: Best practices, regulations and need of regulations

Best practices and regulations for vaccines First-in-humans clinical trials and the need of regulations

Testing of your GCP knowledge: Test your knowledge of the Clinical Research Regulations and GCP

Do you know GCP? Test your knowledge of the Clinical Research Regulations and Good Clinical Practice Guidelines

New FDA guidance for the conduct of research studies during the Covid-19 pandemic

In response to the public health emergency posed by COVID-19 virus, the FDA has issued a Guideline for conducting clinical research during the Covid-19 pandemic..

50% reduction offered to women worldwide for March 8-th, the International Women’s Rights Day

On occasion of the International Day of Women’s Rights, March 8-th, Access Pharma Jobs negotiated with CRA School to help women with university or nursing diplomas to get jobs in the clinical trials’ industry.

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Algeria

KEZADRI KARIMA
Oran, Algeria.
Phone: +213559918058
email: hopekarima@yahoo.fr

Nigeria

David Dele-Davids
Isheri-North, Lagos, Nigeria.
Phone: +2348186303431
email: deledavids@yahoo.com

Asia

Monisha Sundar
Ontario; Canada
New Delhi; India
Phone: +16472387293
             +918427688701
email: mishu_shiv@hotmail.com

Bulgaria

Dr. Jamil Rashed
Sofia, Bulgaria.
Phone: +359879450847
email: Djamilrashed@gmail.com

France

FRANÇOISE INGABIRE
Paris, France.
Phone: +33 7 68 19 04 74
email: ifrancoise@cra-school.com

USA

SMITAL MEHTA
Westminster, Maryland, USA.
Phone: +1-667-367-4006
email: smital.yuva@gmail.com

BC

Benard Kimwei
Burnaby, BC
Phone: +1 403 465 6900
email: benard.kimwei@gmail.com

AB

Olaniyi Taiwo
Edmonton, Alberta
Phone: +1 306 450 2974
email: sotaiwo06@gmail.com

Georgia

Dr. Medea Mikadze
Tbilisi, Georgia.
Phone: +995 599 24 48 47
email: deamikaze@yahoo.com

Ouzbekistan

Dr Zulaykho Shamansurova
Tashkent, Ouzbekistan.
Phone: +998 97 708 8246
email: shamansurova@yahoo.com

Kazakhstan

Aigul Iskakova, MD, CCRA, RA
Alma Ata, Kazakhstan.
email: aigul017@gmail.com

Czech Republic

Serguei Kalynych, PhD, CCRA, MSL
Brno, Czech Republic.
email: skalynych@gmail.com

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