The Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS) will take place virtually, starting tomorrow until the 22nd of April and Asphalion will be there!

Starting on May 26th 2021, integrally-combined DDCs will fall under Article 117 of the MDR.

NEW Pharmacovigilance services at Asphalion.

Demo room at Asphalion´s virtual booth- Global Pharmaceutical Regulatory Affairs Summit 2021

The Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS) will take place virtually from the 20th to the 22nd of April and Asphalion will be there!

ASPHAFORUMS are internal talks delivered by our experts on scientific topics.
In this occasion, because of the relevance of the topic, we would like to share it with you.

2021 has made an energetic start. Many things have happened during the first three months of this year.

The European Commission has launched a call, COVID19 – HERA Incubator, that will mobilize all means and resources necessary to prevent, mitigate and respond to the potential impact of COVID-19 variants.

The Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS) will take place virtually from the 20th to the 22nd of April and Asphalion will be there!

The European research project SBR is developing innovative treatment options for patients with large bone defects through a targeted resorbable bone implant and advanced technologies for the controlled delivery of active molecules to accelerate bone regeneration.

April 7 marks the celebration of World Health Day which aims to create awareness of important aspects of global health.

As of May 2022, IVDR will become fully applicable, displacing the old In vitro diagnostic directive (IVDD).

The date marks the day in 1882 when Dr Robert Koch announced that he had discovered the bacterium that causes tuberculosis, which opened the way towards diagnosing and curing the disease.

Over the past weeks, several news on thromboembolic events potentially related to AstraZeneca’s vaccine for COVID-19 have been largely spread and disseminated.

Software as Medical Device (SaMD) manufacturers will face new challenges to comply with MDR new requirements.

Today, EMA has recommended COVID-19 Vaccine Janssen for authorisation in the EU.

At Asphalion, women represent a 68% of the company, and women at the technical team account for an astounding 66,3%.

This week, Asphalion participated in the kick-off meeting of a new EU H2020, the European funded projects, named In2sight, where we will be the regulatory partners through the development of the project.

The team behind the ARDAT project is trying to answer some of the most perplexing questions surrounding viral gene and cell therapy, in the hope of getting us closer to new treatments for rare diseases. ARDAT wants to know more about the behaviour of gene and cell therapy treatments, delivered by viral vectors, once they’re inside the body.

The #EuropeanCommission has stated that the #UDI/device registration module and the #Certificates and #NotifiedBodies module will become available by September 2021.

Plenty of news regarding COVID-19 vaccines this week.

We actively contribute to bringing treatments to the market and thus improving patient´s lives.

Yesterday, EMA published a Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

Two days ago, EMA notified the start of a rolling review of data on the monoclonal antibody regdanvimab (Celltrion) for the treatment of COVID-19.

Version 2.0 of the European implementation guidance for IDMP has been finally published. Time is of the essence, so nothing catches you by surprise!

Our online conference “Brexit: What´s new for Pharma and Medical Devices”, organized in collaboration with the Department of International Trade and the British Consulate- General in Barcelona provided guidance about Regulatory Affairs and Trade changes in the Pharma and Medical Device industries.

Version 2 of the European IDMP Implementation Guide (EU IG v2) will finally be released on the 22nd of February. This version will not capture all industry comments, but it will cover the most important ones. Versions 2.1 and 2.2 are planned for Q2 and Q3 2021 respectively

The EDQM is preparing a remake of their Certificates of Suitability (CEPs) to provide with an improved tool that can meet the needs of all stakeholders (CEP holders, Industry, Authorities, etc.).

Last week Asphalion, in collaboration with the UK Department of International Trade (DIT) and the British General-Consulate in Barcelona hosted a great online conference about “BREXIT: What´s new for Pharma and Medical Devices”.

BIO-Europe Digital 2020, Europe´s largest springtime digital partnering event, will take place next month, from March 22nd to the 25th. This event will be held digitally and Asphalion will be there!

Starting next week, on the 16th, and extending for 2 mores sessions on the 18th and 22nd of February, the online training course on Regulatory and Scientific Pathways for Global Advanced Therapies Medicinal Products Development aims to give a broad scientific and regulatory overview of the current state of the art and challenges faced by ATMP development.

A significant gender gap has persisted throughout the years at all levels of science, technology, engineering and mathematics (STEM) disciplines all over the world. Even though women have made tremendous progress towards increasing their participation in higher education, they are still under-represented in these fields.