Archives

IN2SIGHT is a project that fosters an unprecedented breakthrough in in-vivo optical imaging that will radically renew the biocompatibility tests of biomaterials. This technology will recast our thinking of biomaterial validation, allowing unprecedented quantitative and longitudinal analyses of the host inflammatory response to the implant.

The HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee will present a webinar featuring four expert speakers who will share regulatory perspectives from both sides of the Atlantic. One of them will be Marta Rayo Lunar, Regulatory and Scientific Affairs Director at Asphalion.

BioSpain, the largest country-based biotech event in Europe will be held in Pamplona and online this year.

Our expert, Lidia Cánovas, General Manager, Regulatory Affairs at Asphalion, will be participating in a roundtable during the event together with four other experts.

World Alzheimer’s Day was launched in 1994 to mark the 10th anniversary of Alzheimer’s Disease International (ADI) and World Alzheimer’s Month a decade ago, and both have grown significantly since then.

World Patient Safety Day was established to enhance global understanding of patient safety, increase public engagement in the safety of health care and promote global actions to enhance patient safety and reduce patient harm.

ASPHALION experts Lidia Cánovas, OriolPenon, Marta Rayo Lunar and Cindy Mancia will attend the congress and will be more than happy to schedule a meeting with you to present you ASPHALION and all the solutions we can provide you with, as well as to discuss all your regulatory needs.

ASPHALION experts Lidia Cánovas and André Mota, together with other three excellent lecturers will share their in-depth knowledge with you and will address the following processes: variation, regulation, classification guideline, eSubmission, and variation management in this course organized by FORUM INSTITUT.

The EU-funded Tumor-LN-oC project proposes the development and validation of a TRL 5 tumor-lymph node-on-chip (Tumor-LN-oC) platform composed of 3D tissue models and microfluidic chips which will connect surgically removed human primary tumors and LN tissue from the same lung cancer patient.

On April 21st, 2021, EMA confirmed that CTIS is fully functional and meets the functional specifications, so that CTIS will be the single entry point for submitting clinical trial information in the EU.

At ASPHALION, we are happy to invite you to our third “RegTalk”, one-to-one talks carried out by experts in different areas, aimed at informing about the latest news in the Regulatory Affairs landscape.

The DMD gene, encoding for the dystrophin protein, is the longest human gene known, since it consists of 79 exons. Because of this, World Duchenne Day is celebrated today.

September has just started and at Asphalion we are beyond happy to announce that the transition to go back to the office in a hybrid manner has begun!

Learn key technology and regulatory aspects to consider in MDSW life cycle management in this eBook. 

The transition from xEVMPD to ISO IDMP is already here. If you have not adapted your processes to capture the new data in your systems, now is the time!!

On June 2nd, 2021, the resolution from the AEMPS to the Regulation (EU) No. 528/2012, which attributes the status of medicine for human use to “antiseptics intended for the preoperative surgical field and for disinfection of the injection site”, came out.

Infographic: US FDA IND Procedures – Regulatory Assistance Current US law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The IND is the means through which the sponsor technically obtains this exemption from the FDA. During a new drug’s early preclinical development, […]

From ASPHALION we would like to announce that have prepared a series of 4 Webinars on Data Management for the coming quarter.

The deadline for the first calls regarding HORIZON EU-granted projects, September the 21st, is approaching. Every call needs a mix of partners in order to fill its requirements. If at this stage you still do not have a Regulatory partner for your project, we suggest you contact us.

August is coming to and end, and so is Asphalion´s Regulatory Affairs Summer QUIZ.

Since January 1st, 2021, Medical Device manufacturers located outside the United Kingdom and without any local business offices shall appoint a United Kingdom Responsible Person (UKRP), on their behalf, as a pre-requisite for device registration and launch of the device in the United Kingdom.

From ASPHALION, we would like to inform you of the opening of the call:

HORIZON-HLTH-2021-TOOL-06-01: Smart medical devices and their surgical implantation for use in resource-constrained settings

At ASPHALION, we invite you to our second “RegTalk”, one-to-one talks carried out by experts in different areas, aimed at informing about the latest news in the Regulatory Affairs landscape.

From ASPHALION, we would like to inform you of the opening of the call:

HORIZON-HLTH-2021-DISEASE-04-04: Clinical validation of artificial intelligence (AI) solutions for treatment and care

https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2021-disease-04-04

On April 21st, 2021, EMA confirmed that CTIS is fully functional and meets the functional specifications, so that CTIS will be the single entry point for submitting clinical trial information in the EU.

From ASPHALION, we would like to inform you of the opening of the call:

HORIZON-HLTH-2021-STAYHLTH-01-02. Towards a molecular and neurological understanding of mental health and mental illness for the benefit of citizens and patients

https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2021-stayhlth-01-02

We are starting a new month, August, but at Asphalion our activity does not stop!

At ASPHALION, we are proud to introduce “RegTalk”, one-to-one talks carried out by experts of different areas, aimed at informing about the latest news in the Regulatory Affairs landscape.

From ASPHALION, we would like to inform you of the opening of the call:

HORIZON-HLTH-2021-TOOL-06-02: Next generation advanced therapies to treat highly prevalent and high burden diseases with unmet medical needs

Today, on World Hepatitis Day, the world comes together to raise awareness of hepatitis, one of the most deadly and neglected diseases and health crises.

From ASPHALION, we would like to inform you of the opening of the call:

HORIZON-HLTH-2021-DISEASE-04-07: Personalised medicine and infectious diseases: understanding the individual host response to viruses (e.g., SARS-CoV-2)

Do you have all your organisation information up to date in SPOR? EMA has recently communicated that the use of Organisation Management Service (OMS) in the eAF for CAP will be mandatory.

At ASPHALION, we have experience as Regulatory Partners in more than 14 European granted projects, providing Regulatory Affairs support throughout the whole project duration.