Go-live planning of the new EudraVigilance system

The EudraVigilance System is going to be scheduled for downtime from 8th  to 21st of  November 2017.

The Agency will be releasing the new EudraVigilance system on 22th of November. This follows the EMA Management Board announcement in May that the EudraVigilance (Human) system has achieved full functionality. A number of planned tasks and activities are necessary to prepare for the release of the new EudraVigilance system, requiring a downtime period of 10 business days from 8 to 21 November. The scheduled downtime will affect a number of key EudraVigilance functionalities and several other IT systems and business processes.

For more information on the impacted IT systems, including EudraVigilance, business processes and the alternative arrangements, please click here or on the link below:

EudraVigilance System downtime


PSN Research at 25th UEG Week Barcelona 2017

Taking place for the 25th time, UEG Week is the largest and most prestigious GI meeting in Europe and is now a global congress. UEG Week attracts around 14,000 participants each year, from around the world.

UEG, or United European Gastroenterology Week is an opportunity to present new research and thinking across a wide range of digestive disease areas, cutting-edge post-graduate teaching sessions, some of the best GI abstracts and posters and simultaneous live streams to a global audience and endoscopic, ultrasound and surgical hands-on training.

The focus for the 25th UEG Week 2017 in Barcelona will be to advance science and link people in the global GI community. UEG’s mission is to continuously improve standards of care in gastroenterology, and promote ever greater understanding of digestive and liver disease – among the public and medical experts alike.

 

For further information please clink the link below:

https://live.ueg.eu/week/

 


Sermes CRO a PSN Research Company is a Tester of the New EMA´s EU Portal (UATs)

The EMA (European Medicines Agency), retakes the development of the new portal for the online presentation of clinical trials at European level (UATs European portal).
This October 2017 will take place the next step, “test the new portal by a group of experts” carefully selected by EMA itself. In total, the EMA has entrusted 16 European representatives with the task of testing “onsite” the new Portal (UATs) through on-site E2E scenarios, in a face-to-face manner in their offices in London.

EUCROF (European CRO Federation), has determined that Sermes CRO a PSN Research Company, represented by their Head of Unit of start-up (UPM), Lidya Dominguez, will be person chosen to go to the offices of the EMA and to carry out the “on-site” UATs test to analyze possible errors and To bring new ideas of improvement to implant in the Portal.

For more information, click on the following links:

Presentation of Eu Portal and Database project


The EMA presents the EU regulatory system

The European Medicines Agency (EMA)  hosted an awareness session to present the European Union’s (EU) medicines regulatory system and EMA’s role in it to international regulators and non-governmental organisations.

All the speakers were part of the Agency and will present on the European medicines regulatory network and the various activities carried out by EMA as part of it. The issue will be to show a clear understanding of how medicines are regulated in different parts of the word is of prime importance in an increasingly globalised world where regulators rely on close cooperation.

Topics include:

  • European Union (EU) marketing authorisation procedures
  • Support to innovation
  • Benefit/risk assessment of new medicines
  • Pharmacovigilance activities
  • Stakeholder engagement

The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.

This network is what makes the EU regulatory system unique. The network is supported by a pool of thousands of experts drawn from across Europe, allowing it to source the best possible scientific expertise for the regulation of medicines in the EU and to provide scientific advice of the highest quality.

EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information. They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials and the conduct of inspections of medicines’ manufacturers. This works because EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines.

For more information, please see the programme.


Addendum on estimands and sensitivity analysis to the guideline on statistical principles in clinical trials

 

The European Medicines Agency has released for public consultation following guidance document:

The E9(R1) addendum aims to clarify and extend ICH E9 by elaborating on the choice of estimand and sensitivity analysis in clinical trials, providing a framework to align its planning, design, conduct, analysis and interpretation. Having clarity in the trial objectives and accounting explicitly for intercurrent events when describing the treatment effect of interest at the planning stage of a clinical trial are crucial for a clear description of the effects of a medicine.

The proposed framework aims to facilitate dialogue for the disciplines involved at the planning level of the trial and also between sponsors and regulators regarding the treatment effects of interest that a clinical trial should address. The statistical analysis, aligned to the estimand, will be associated with assumptions and data limitations, the impact of which can be investigated through sensitivity analysis, whose definition and role are clarified in this addendum.

Deadline for comments will be 28 February 2018.

Please for more information please click on the link below:

European regulatory system for medicinesr brochure

EMA document


Advances in Stem Cell Therapy for Lung Diseases

University of North Carolina Health Care researchers have made strides toward a stem cell treatment for lung diseases such as pulmonary fibrosis, COPD, and cystic fibrosis.

In fact, they are discussing the start of clinical trials with regulatory authorities.

The team discussed its work in two recent studies. One proved that it is possible to isolate lung stem cells with a relatively non-invasive procedure. The other showed that stem cells reduce fibrosis in rats with pulmonary fibrosis.

“This is the first time anyone has generated potentially therapeutic lung stem cells from minimally invasive biopsy specimens,” Dr. Jason Lobo, director of the university’s lung transplant and interstitial lung disease program, said in a press release. He was co-senior author of both studies.

The research team had previously homed in on stem and support cells they could isolate from a lung tissue sample and grow in a lab. The tissue formed sphere-like structures in a lab dish, prompting the scientists to call them lung spheroid cells.

In 2015, the team showed that these cells had potent regenerative properties in animals with lung diseases. In fact, the stem cells they cultivated outperformed another type called mesenchymal stem cells.

For further information, please check the links below:


The EMA: Science and innovation for better medicines

PATIENTS AND THEIR NEEDS ARE AT THE CENTER OF ALL ACTIVITIES OF THE AGENCY

The European Medicines Agency (EMA) ensures that medicines which are prescribed and used across the European Union (EU) are Safe, Effective and of Good Quality.All of them are carefully evaluated by the bests scientific experts through the European regulatory network assuring each new medicine it is recommended for authorisation if the benefits for the patients outweigh the risks of possible side effects.

The document created, entitled Enabling science that works for patients (at link below), try to explain  how The EMA promotes science and innovation in order to find better medicines, collaborates closely with patients to understand their point of view and to make sure that new medicines address their needs,   providing also a scientific advice and guidance to encourage the development of new and innovative medicines, especially in areas with limited treatment options such as rare diseases and illnesses in children.

EMA involves patients, consumers and their representative organisations in all decisions made during the lifecycle of a medicine in the:

  • Development of policies
  • Regulatory guidance
  • The evaluation and safety monitoring of medicines

To see the deatiled leaflet created by The EMA, pleach clink on the link below:

Enabling science that works for patients


A unique source of information on safety and effectiveness of authorised drugs is registered as EU trade mark

The EU PAS Register was launched in November 2010 as unique source of information on the safety and effectiveness of authorised medicines. This platform is openly and accessible which includes information on observational post-authorisation research in medicines already marketed in EuropePSNResearch

and some infor that includes is:

  • Study protocols
  • Study results
  • Related publications
Data from 31st f July 2017 – EU PAS Register Platform

All the information at the EU PAS Register helps to reduce publication bias through increased transparency of medicines research, improves the quality of post-authorisation studies by facilitating peer-review of protocols and results, promotes collaboration among stakeholders, and ensures compliance with EU pharmacovigilance legislation requirements.

 The platform is recommended in the following cases: scientific publications, guidelines and textbooks. Although initially the main aim of The EU PAS Register was to collect studies conducted in the European Union, researchers from outside the EU are also registering studies to increase transparency of their research.

The EU PAS Register was developed through the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by EMA to support research in pharmacoepidemiology and pharmacovigilance.

If you want to consult more info abour EU PAS Register Platform, please click on the link below:

EU PAS Register


The EMA Agreed on principles for involving young people under 18 in their activities

New principles give a voice to patients, consumers and carers under age 18 can make an important contribution to EMA’s committee discussions on medicines by sharing their experience and perspectives of living with a disease or condition.

These principles set out best practice for the interaction between parties on:

  • Discussion in small groups
  • Provision of specific support
  • Use of appropriate language
  • Obtaining parental consent
  • Protection of personal data
  • The privacy of the young patients.

 

The key forum in which young people could participate in the Agency’s activities would be its Paediatric Committee (PDCO), but experience has demonstrated that the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Scientific Advice Working Party (SAWP) can also benefit from this input when these groups review medicines for children.

For more information about this notice, please check the links below:

Involving young people in EMA activities

THE EMA HOME

PRINCIPLES OF INVOLVING YOUNG PEOPLE ON THE EMA´s ACTIVITIES


FDA Panel Recommends Approval for the First Gene Therapy in Leukemia Treatment

A FDA panel opened a new era in medicine unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease.

The treatment will be The First Gene Therapy ever to reach the market throw FDA approval. 

A single dose of the resulting product has brought long remissions, and possibly cures, to scores of patients in studies who were facing death because every other treatment had failed. The panel recommended approving the treatment for B-cell acute lymphoblastic leukemia that has resisted treatment, or relapsed, in children and young adults aged 3 to 25.

In 2012, as a 6-year-old patient was treated in a study at the Children’s Hospital of Philadelphia. Severe side effects — raging fever, crashing blood pressure, lung congestion — nearly killed her. But she emerged cancer free, and has remained so. 

Her father said to FDA comitte“I hope that someday all of you on the advisory committee can tell your families for generations that you were part of the process that ended the use of toxic treatments like chemotherapy and radiation as standard treatment, and turned blood cancers into a treatable disease that even after relapse most people survive.”

The main evidence  presented by the sponsor to the FDA came from a study of 63 patients who received the treatment from April 2015 to August 2016:

  • 52 of them, (82.5%) went into remission — a high rate for such a severe disease.
  • 11 of them died

As NY times sahred on their interview: “It’s a new world, an exciting therapy,” said Dr. Gwen Nichols, the chief medical officer of the Leukemia and Lymphoma Society, which paid for some of the research that led to the treatment. The next step,  will be to determine “what we can combine it with and is there a way to use it in the future to treat patients with less disease, so that the immune system is in better shape and really able to fight. This is the beginning of something big.”