Visit Asphalion´s virtual booth at the Global Pharmaceutical Regulatory Affairs Summit 2021 and help the environment!

April 19, 2021

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

Webinar | Medical Device Regulation (MDR) impact in Pharma Industry: Article 117

April 19, 2021

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

NEW Pharmacovigilance services

April 16, 2021

NEW Pharmacovigilance services at Asphalion.

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

April 16, 2021

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

“IDMP: Where to start”. Asphalion talk at the Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS)

April 15, 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!

ASPHAFORUM: Covid-19 vaccine safety signal

April 15, 2021

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.

Asphalion´s highlights: First quarter 2021

April 14, 2021

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

Vaccines & therapeutic clinical trials to boost COVID-19 prevention and treatment

April 13, 2021

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.

Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS)

April 13, 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!

Improved treatment options for patients with large bone defects: Horizon2020 project SBR releases animated clip

April 8, 2021

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.

WORLD HEALTH DAY 2021

April 7, 2021

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

IVDR AWARENESS

April 6, 2021

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

World Tuberculosis Day

March 24, 2021

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.

AstraZeneca vaccine for COVID-19: benefits and risks

March 23, 2021

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

#BHHSERIES- MEDICAL DEVICE WEBINAR | “Medical Device Regulation (#MDR) for medical software: Are you ready?”

March 12, 2021

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

COVID-19 LATEST NEWS

March 11, 2021

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

International Women´s Day 2021

March 8, 2021

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

In2sight kick-off meeting

March 5, 2021

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.

ARDAT project update

March 5, 2021

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.

Update on EUDAMED

March 4, 2021

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

Latest news: Vaccines authorized or under evaluation by EMA

March 4, 2021

Plenty of news regarding COVID-19 vaccines this week.

Rare Disease Day 2021

February 28, 2021

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

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

February 26, 2021

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

COVID-19 UPDATE

February 26, 2021

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.

IDMP version 2.0 has been published

February 22, 2021

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!

Complete online conference video of: “BREXIT: What´s new for Pharma and Medical Devices”

February 19, 2021

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.

IDMP updates

February 18, 2021

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

Certificates of Suitability (CEPs)

February 17, 2021

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.).

Online conference highlights video of: “BREXIT: What´s new for Pharma and Medical Devices”

February 16, 2021

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 Spring Digital 2021

February 15, 2021

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!

Register now for the Regulatory and Scientific pathways for global advanced therapies medicinal products development (ATMPs) course by LS Academy!

February 11, 2021

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.

International Day of women and girls in science

February 11, 2021

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.