Faus & Moliner participates in the «International Comparative Legal Guide to Drug & Medical Device Litigation 2021»
Xavier Moliner and Juan Martínez write the chapter dedicated to drug and medical device litigation in Spain
INTERNATIONAL COMPARATIVE LEGAL GUIDE
The 2021 edition of the International International Comparative Legal Guide to Drug & Medical Device Litigation magazine is now available. The Guide offers a practical insight into drug and medical devices litigation issues across the world. Xavier Moliner and Juan Martinez were in charge of chapter 16 dedicated to drug and medical device litigation.
Al final todo llega
El Global
El reglamento europeo sobre ensayos clínicos, aprobado en 2014, preveía la creación de un portal único a través del cual se canalizarían todas las comunicaciones entre los distintos agentes implicados en la solicitud, evaluación y autorización de los ensayos clínicos con medicamentos llevados a cabo en la UE. También preveía la creación de una base... Read More
Gracias por el desayuno
El Global
El pasado lunes participé en un desayuno sobre acceso a medicamentos organizado por la Federación Española de Enfermedades Raras (FEDER). Dicho encuentro reunió a organizaciones de pacientes, representantes parlamentarios y profesionales sanitarios y en él se vertieron distintos puntos de vista y se identificó (entre muchos otros) un problema: el camino desde la autorización de... Read More
Approval process for COVID-19 vaccines v.2
Adaptation of vaccines to new SARS-CoV-2 variants
Capsulas Nº 216
Introduction On 23 December 2020, two days after the European Medicines Agency (EMA) issued its favorable opinion on the authorization of the Covid-19 vaccine developed by BioNTech and Pfizer and, in a context in which there were voices expressing certain concern about the safety of the vaccines, we published a special CAPSULAS aimed to dispel... Read More
The importance of quality and safety controls for medical devices
Judgement of the Supreme Court of 1 March 2021
Capsulas Nº 216
Background A manufacturer of a hip prosthesis, after becoming aware that the product had to be revised more often than expected, issued a safety notice recommending wearers of the affected prosthesis to follow a specific monitoring and control plan. Several months later, the manufacturer voluntarily withdrew the product from the market. Afterwards, a patient underwent... Read More
Sanidad, Anefp y Autocontrol lo tienen claro: Mejor prevenir que curar
El Global
El BOE ha publicado el convenio de colaboración, en materia de publicidad de medicamentos dirigida al público, suscrito entre el Ministerio de Sanidad, la Asociación para el Autocuidado de la Salud (Anefp) y la Asociación para la Autorregulación de la Comunicación Comercial (Autocontrol). Este convenio, suscrito el 22 de marzo de 2021, sustituye a otro... Read More
Estudios Observacionales y Programas de Soporte a Pacientes: Comentarios al Real Decreto 957/2020
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 76, JANUARY-MARCH 2021
This article aims to describe and comment the regulatory framework applicable to observational studies with medicines for human use foreseen in Royal Decree 957/2020. Likewise, it provides the opinion of the authors with respect the ongoing debate regarding the impact of such Royal Decree on the regime applicable to patient support programs.
I love my lawyer
El Global
Hoy les hablaré de uno de los signos distintivos a mi juicio más relevantes en el ejercicio de la abogacía, que también compartimos con la profesión médica: el secreto profesional. Ambas profesiones se basan en una relación de confianza, ya sea abogado-cliente o médico-paciente, que imponen a quienes la desempeñan el derecho, y también el... Read More
Faus & Moliner participates in «The Legal 500: Product Liability Country Comparative Guide»
Xavier Moliner and Juan Martínez write the chapter regarding product liability in Spain
The Legal 500 Country Comparative Guides
The aim of this guide is to provide its readers with a general overview of current Product Liability laws and regulations in each of the jurisdictions to which it refers. Each chapter of this guide provides information about objective product liability, non-contractual and contract liability and litigation that can be raised on these matters.
Faus & Moliner participates in the “Chambers Global Practices Guides – Pharmaceutical Advertising 2021″
Jordi Faus, Verónica Carías and Laura Marquès write the chapter about Law and Practice in Spain
CHAMBERS GLOBAL PRACTICES GUIDE
The ‘Law & Practice’ sections provide easily accessible information on navigating the legal system when conducting business in the jurisdiction. Leading lawyers explain local law and practice at key transactional stages and for crucial aspects of doing business.