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Human Microbiomes in Health & Disease Voisin Consulting Life …

WEBManfred Ruthsatz, PhD, RAC, FRAPS, is the executive director of Nutrition+HealthCARE, Connecting Advocacy, Regulatory, and Empathy. His healthcare …

Actived: 5 days ago

URL: https://voisinconsulting.com/resources/publications/human-microbiomes-in-health-and-disease-strategic-options-for-regulatory-science-and-healthcare-policy/

New FDA Guidance on Multiple Function Device Products & Its …

WEBWe can speculate it is going to be more and more common with the development of e-health platforms hosting different modules with clinical, educational, or administrative …

Category: Health Go Health

Food and Drug Administration (FDA or USFDA)

WEBThe FDA consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary …

Category: Food, Medical Go Health

Digital Health Series

WEBBlog Digital health. Digital Health Series – Part 1: Defining Software as a Medical Device. Recently, the United Kingdom Medicines and Healthcare products …

Category: Medical, Medicine Go Health

Investigational Medicinal Product Dossier (IMPD)

WEBThe Investigational Medicinal Product Dossier is a document divided in four distinct sections. It provides information on (i) the quality, manufacture and control of the IMP, …

Category: Health Go Health

Market Access Voisin Consulting Life Sciences

WEBVCLS has a strong understanding of HealthTech investors’ requirements and has helped hundreds of emerging biopharmaceutical and medical technology companies build their …

Category: Medical Go Health

What are the reimbursement pathways for innovative digital …

WEBInnovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers are starting to cover software-based healthcare …

Category: Health Go Health

About VCLS Voisin Consulting Life Sciences

WEBAbout. Voisin Consulting Life Sciences guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. VCLS assists …

Category: Health Go Health

FOODS AND NUTRACEUTICALS

WEBFOODS AND NUTRACEUTICALS. Food products are consumed for a feeding purpose or for the benefit of health maintenance and wellbeing. They are composed of nutrients …

Category: Food Go Health

Digital Health Series

WEBBlog Digital health. Digital Health Series – Part 2: Software as a Medical Device Regulated by the US FDA. Artificial Intelligence has achieved major milestones …

Category: Medical Go Health

Regulatory & Health Economic Expert Resources

WEBGlobal Product Development Strategy – Communication with Regulators & Payers. Discover how VCLS helps pharmaceutical, biotechnology and medical device …

Category: Medical Go Health

Voluntary Harmonization Procedure (VHP)

WEBCorporate Social Responsibilities. our expertise. By Stage of Drug Development. By Stage of Medical Device Development. Product Expertise. Industry Focused. Therapeutic …

Category: Medical Go Health

Late-Stage Clinical Development

WEBPre-Clinical Development Determine the safe dose for FIH study Early-Stage Clinical Development Assess efficacy, effectiveness and safety Late-Stage Clinical Development …

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Suspected Unexpected Serious Adverse Reaction (SUSAR)

WEBSuspected Unexpected Serious Adverse Reaction. Suspected Unexpected Serious Adverse Reaction is the term used to refer to an adverse event that occurs in a clinical trial …

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Serious Adverse Event (SAE) Voisin Consulting Life Sciences

WEBAdverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans, whether or not considered drug related. An …

Category: Medical Go Health

Afterwork: Key Takeaways from JP Morgan’s Annual Healthcare …

WEBPartner at Sofinnova Partners. Matthieu focuses on Sofinnova’s new biotech accelerator Biovelocita. With nearly two decades of venture capital and operational …

Category: Health Go Health

Solutions for Switzerland

WEBThe Swiss pharmaceutical market is independent of the European Union (EU), with the distinct regulatory framework, legislations, and regulatory authorities. With the 3rd …

Category: Health Go Health

EMA HTA Parallel Scientific Advice

WEBSince 2010, the EMA has put in place a pilot project of Parallel Scientific Advice (EMA/HTA SA) with the participation of 13 of the HTA bodies that allows developers to receive …

Category: Health Go Health