New Clinical Trials Regulation in Europe

Clinical Trials Regulation (EU) No 536/2014

December 2, 2021

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Hair Disorders and Emerging Treatments

Hair Disorders and Emerging Treatments

November 9, 2021

Although hair disorders are common, their management still represents a major clinical challenge in dermatological practice despite the emergence of new diagnostic tools and new treatment options.

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World Psoriasis Day

World Psoriasis Day

October 29, 2021

Today is World Psoriasis Day. It is a great opportunity to share a review of the literature on this chronic skin pathology.

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Breast Cancer Screening Awareness Month

Breast Cancer Awareness Month

October 12, 2021

October is Breast Cancer Screening Awareness Month.

More than 355,000 women were newly diagnosed with breast cancer, and nearly 92,000 women died from the disease across the EU-27 in 2020.

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International Translation Day

Journée Internationale Traduction

September 30, 2021

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The CONSERVE 2021 Statement for reporting changes in studies

CONSERVE 2021 statement

September 7, 2021

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First International Neonatal Screening Day

International Neonatal Screening Day

June 28, 2021

Neonatal screening, also called newborn screening (NBS), allows the early detection and clinical management of newborns with a range of health conditions.

The date for this international NBS day was chosen in honor of Dr. Robert Guthrie, whose birthday is June 28th. In the United States in the 1960s, Dr Guthrie developed the first NBS test for phenylketonuria (PKU), using a drop of blood collected on blotting paper. This blotting paper technique is still used today in all NBS programs. The blood sample is usually collected in the first 3 days of life from the newborn’s heel, or sometimes from their hand.

Technological advances now allow the screening of up to 50 disorders from just a few dried blood spots! Most of these are congenital metabolic disorders and endocrine disorders.

France was a pioneer in NBS, with the setting up of a national screening program in 1972. Since then, more than 35 million newborns have been screened, allowing earlier management of more than 23,500 individuals. In France, the cost of NBS is 100% covered by the health insurance system. NBS is not mandatory, but “refusing screening would be highly detrimental for the child” (Haute Autorité de Santé, HAS).

Six rare diseases are currently screened as part of the NBS program in France: phenylketonuria (PKU), congenital hypothyroidism (CH), sickle cell disease (SCD; overseas, and in mainland France if risk factors identified), congenital adrenal hyperplasia (CAH), cystic fibrosis (CF) , and medium-chain acyl-CoA dehydrogenase deficiency. However, this is much fewer than the more than 20 diseases screened in some European countries, such as in Italy where the NBS program includes up to 31 diseases!

The HAS recommends adding 7 inborn errors of metabolism to the French national NBS program: maple syrup urine disease (MSUD), homocystinuria (HCY), type 1 tyrosinemia (TYR-1), type 1 glutaric aciduria (GA-1), isovaleric acidemia (IVA), long chain hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, and carnitine uptake defect (CUD).

World Microbiome Day

World microbiome day

June 24, 2021

June the 27th is World Microbiome Day. This yearly event aims to raise awareness of the diversity of human, animal and environmental microbiomes, and of their effects on health.

Our medical writers at Santé Active Edition – Synergy Pharm have participated in the writing of several scientific articles and reviews on the skin and intestinal microbiomes, highlighting their vital importance for human health, most notably in acne, atopic dermatitis, rosacea, wound healing, and in intestinal disorders. In addition, microbiomes in the environment play a fundamental role in maintaining the balance needed for healthy ecosystems.

MedComms Day


June 9, 2021

Today is MedComms Day! We would like to take this opportunity to tell you about our core business activity: medical and scientific writing.

Our medical communication agency has been serving the pharmaceutical and cosmetics industries, biotech companies, manufacturers of medical devices, healthcare professionals, and the wider scientific research community for more than 30 years. How? Medical communication, and particularly the writing of regulatory and clinical documentation related to the development of drugs and other healthcare products, is an integral part of these sectors.

  • Setting up a clinical study requires the submission of a Clinical Trial Authorization (CTA) application to the health regulatory authorities. Many documents need to be written for this application: an Investigational Medicine Product Dossier (IMPD), an investigator’s brochure, a synopsis and a clinical trial protocol, an informed consent form (ICF), etc. In addition, a Clinical Study Report (CSR) needs to be written after each trial phase to communicate the results to the regulatory authorities, and a lay summary must also be published in the European database of clinical studies.
  • Preparing a drug Marketing Authorization Application (MAA) also requires specific skills, involving the writing of a Common Technical Document (CTD, clinical and nonclinical), and a Pediatric Investigation Plan (PIP), if applicable. After submitting the MAA dossier, national (e.g., the French Agency for the Safety of Medicines and Health Products, ANSM) or international (European Medicines Agency [EMA], Food Drug Administration [FDA]) health agencies usually require detailed responses to answer specific questions about the drug being assessed.
  • Pharmacovigilance documents (e.g., Periodic Safety Update Reports [PSURs], Development Safety Update Reports [DSURs] are also essential documents that need to be written at various points during the “lifespan” of a drug.

Our team is passionate about scientific and medical writing: our profession is diverse and enriching with many various missions on many various themes!

World No Tobacco Day

World No Tobacco Day

May 31, 2021

Did you know that tobacco is the main risk factor for bladder cancer?

In 75% of cases, bladder cancer is non-invasive but 5-year progression (0.8% – 45%) and recurrence (31% – 78%) rates are high. Patients with this type of cancer must therefore undergo regular examinations to enable early treatment.

Several urinary tests have been developed to overcome the drawbacks of reference examination methods;  in particular the invasive nature of cystoscopy, and the problems of sensitivity and of intra- and inter-observer reproducibility associated with cytology.