Following on the exit of the UK from the EU on 31st Jan 2020, this year’s MHRA Good Pharmacovigilance Practice (GPvP) Symposium was well attended and eagerly awaited by the pharmacovigilance professionals within the industry.
Asphalion is the regulatory partner for a successfully funded Horizon 2020 project entitled “Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination”, MISTRAL.
As of 1 February 2020, the United Kingdom (UK) is no longer an EU Member State and acts as a third country. This means that the UK no longer participates in EU institutions and their decision-making.
At Asphalion we work together with our clients to generate ideas and implement solutions that contribute to improve people’s quality of life.
Asphalion is very pleased to announce the start of the collaboration with Maria Molist for the provision of pharmacovigilance/regulatory services in the UK.
Asphalion is attending the SBR H2020 project kick-off meeting. Within the SBR project, Asphalion will provide continuous regulatory support to all partners during the whole duration of the project.
Clinical Trials Results: The Lancet study suggests that compliance still needs to improve, especially with smaller and academic sponsors.
MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards
UPDATE: The corrigendum for the EU’s Medical Devices Regulation (MDR) granting manufacturers of Class I devices upclassified under MDR a four-year transitional period has been approved and published.
May 2020 is round the corner and therefore, only a few months remain for date of application (DoA) of the new medical device regulation (MDR).
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Last week Asphalion attended the second edition of the “Forum d’Empreses de l’ámbit farmacèutic – sanitari“, organised by the Facultat de Farmàcia I ciències de l’alimentació de la Universitat de Barcelona.
Yesterday, Asphalion’s values (commitment flexibility passion and teamwork) were demonstrated in a 17 km hike organized and walked by members of the company who traveled with family & friends from our offices in Barcelona to Sant Cugat del Vallès.
Last week, our colleagues Marta Rayo Lunar and Marta Morales attended the n-TRACK Project Review Meeting in Cambridge to discuss the project progress with all the partners.
Yesterday, November 6, Dominique Monferrer and Eduardo Garrido participated in the event Graphene Connect on MedTech and Diagnostic Technologies associated with the first Graphene for Health Investment Forum.
Yesterday, Consol Bozzo Mulet and Daniel Langa García gave a training session on regulatory approach of “ICH Q12: Control de cambios. Consideraciones técnicas y regulatorias en el ciclo de vida de los productos farmacéuticos.”.
In June 2019, the EC, the EMA and the HMA co-signed a letter reminding all sponsors of clinical trials conducted in the EU of their obligation to make summaries of results of concluded trials publicly available in the EudraCT.
Two months after being designated as the third Notified Body (NB) under the Medical Devices Regulation (MDR), Dekra Certification GmbH was annouced last week by the European Commission (EC) as the first NB to be designated under the EU In Vitro Diagnostic Regulation (IVDR).
With the entry into force of the new Medical Devices Regulation (2017/745/EU, “MDR”), many new requirements to be met by the manufacturers have been established.
As published in the Electronic submissions for CEP applications Revised Roadmap 2016-2020, from January 2020, EDQM will require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only).