European Medicines Agency

Connection template - EMA ESTRI Gateway using an AS2 compatible product

Retrieved on: 
Sunday, March 10, 2024

29 February 2024

Key Points: 
  • 29 February 2024
    EMA/385068/2017
    Information Management Division

    Connection template - EMA ESTRI Gateway
    using an AS2 compatible product

    For Safety Reports – ICSRs/ SUSARs
    The information of the EMA system is shown below and it should be sufficient for you to
    create a profile of the EMA ESTRI gateway on your system.

  • You will be required to provide your gateway details in a blank gateway connection form
    following the example below.
  • AS2 partners → EMA:
    Need to add 18.156.142.227 (PROD and XCOMP), TEST (3.121.50.54) in
    your firewall only if you restrict outgoing traffic at your firewall when sending files to EMA.
  • Please note that we do not block any incoming traffic, the pgateway is open to entire
    Internet

    Connection template - EMA ESTRI Gateway
    EMA/385068/2017

    Page 2/2

Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 1 March 2024, 09:30 (CET) to 1 March 2024, 15:40 (CET)

Retrieved on: 
Sunday, March 10, 2024

The next chapter will concern human and veterinary Adverse Drug Reactions (ADRs) arising from all sources (e.g.

Key Points: 
  • The next chapter will concern human and veterinary Adverse Drug Reactions (ADRs) arising from all sources (e.g.
  • The aim of this workshop is to bring together experts in the field to build on their extensive experience and knowledge relating to ADR data quality.
  • We anticipate space for a broad representation of stakeholders; attendance will be organised through EU associations and by direct invitation.
  • Registration
    Online participation (via Webex) is organised via EU associations and direct invitations to allow a broad range of stakeholders to participate.

Clinical Trials Information System Webinar: Last Year of Transition, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 March 2024, 13:00 (CET) to 25 March 2024, 17:30 (CET)

Retrieved on: 
Sunday, March 10, 2024

Since 31 January 2023, it is mandatory for sponsors to submit all initial clinical trial applications via CTIS.

Key Points: 
  • Since 31 January 2023, it is mandatory for sponsors to submit all initial clinical trial applications via CTIS.
  • In less than a year, from 31 January 2025 onwards sponsors will need to comply with their obligations under the CTR and its Delegated Acts.
  • This EMA-hosted webinar is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.
  • Attendees are invited to fill out a short feedback survey via Slido that will be available after the event.

Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 18 March 2024

Retrieved on: 
Sunday, March 10, 2024

Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting

Key Points: 
  • Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting
    This meeting is organised is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations.
  • EventHumanMedicines
    Date
    Location
    This meeting between European Medicines Agency (EMA) and MedTech Europe is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations.
  • The purpose of the meeting is to exchange views and promote dialogue on topics of common interest such as MedTech Europe priorities for 2024-2029; implementation of medical device, in vitro diagnostic regulations and EMA extended mandate, impact to Medical Device sector represented by legislative/policies EU proposals and other relevant initiatives.

EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions?, Online, European Medicines Agency, Amsterdam, t[...]

Retrieved on: 
Sunday, March 10, 2024

This workshop will bring together international experts from academia, learned societies, patients, regulatory agencies, health technology assessment bodies, and industry.

Key Points: 
  • This workshop will bring together international experts from academia, learned societies, patients, regulatory agencies, health technology assessment bodies, and industry.
  • The aims of the workshop are to:
    - Understand the current global landscape on the use of PROs and HRQOL for evaluation of anti-cancer treatments across different stakeholder groups.
  • - Understand the use of validated PRO questionnaires to measure core HRQOL outcomes and disease-related symptoms; and PRO Item Libraries in the development of trial-specific/treatment-specific item lists.
  • The recording of this meeting will be made available after the event.

Cancer Medicines Forum workshop: April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 April 2024, 13:00 (CEST) to 5 April 2024, 18:00 (CEST)

Retrieved on: 
Sunday, March 10, 2024

The deliverables of the CMF are aimed at supporting policy decisions to facilitate treatment optimisation in Europe with a focus on post-licensing questions based on clinically relevant end-points for patients in the healthcare setting.

Key Points: 
  • The deliverables of the CMF are aimed at supporting policy decisions to facilitate treatment optimisation in Europe with a focus on post-licensing questions based on clinically relevant end-points for patients in the healthcare setting.
  • Registration
    You can register to the workshop at the following link:
    Registration will close on 1 March 2024 for in-person participation.
  • In-person participation will be confirmed by 8 March 2024 and will be based on the capacity of the venue and distribution amongst several stakeholders.
  • Video recording
    The workshop will be broadcast live and a recording of this meeting will be made available after the event.

SK bioscience Breaks Ground on Manufacturing Facility Expansion for Extending Product Pipeline

Retrieved on: 
Thursday, March 7, 2024

The new space will serve as a production base for the pneumococcal conjugate vaccine candidate, co-developed by SK bioscience and Sanofi.

Key Points: 
  • The new space will serve as a production base for the pneumococcal conjugate vaccine candidate, co-developed by SK bioscience and Sanofi.
  • In addition to facility expansion, SK bioscience plans to quickly obtain cGMP (Current Good Manufacturing Practice) certification for the new facility, which is the standard for pharmaceutical manufacturing and quality management in the United States, to enhance global competitiveness.
  • SK bioscience and Sanofi plan to utilize the expanded manufacturing facility to accelerate the successful introduction of GBP410 into the global market, including United States, Europe, and South Korea.
  • Jaeyong Ahn, CEO of SK bioscience, said, "L HOUSE, which demonstrates global competitiveness in manufacturing capabilities, will firmly establish itself as a global vaccine hub through this expansion.

Rare Disease Day 2024 - Call for greater awareness of X-linked adrenoleukodystrophy and cerebral adrenoleukodystrophy - special film launched

Retrieved on: 
Thursday, February 29, 2024

The film can be found on Neuraxpharm's and Minoryx's websites, YouTube and LinkedIn channels.

Key Points: 
  • The film can be found on Neuraxpharm's and Minoryx's websites, YouTube and LinkedIn channels.
  • Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, said: "The impact this disease has on patients and their families cannot be overstated.
  • We hope that this film will raise awareness and understanding of the condition."
  • Minoryx and Neuraxpharm strongly believe that leriglitazone has a positive benefit / risk balance in patients with cALD.

Rare Disease Day 2024 - Call for greater awareness of X-linked adrenoleukodystrophy and cerebral adrenoleukodystrophy - special film launched

Retrieved on: 
Thursday, February 29, 2024

The film can be found on Neuraxpharm's and Minoryx's websites, YouTube and LinkedIn channels.

Key Points: 
  • The film can be found on Neuraxpharm's and Minoryx's websites, YouTube and LinkedIn channels.
  • Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, said: "The impact this disease has on patients and their families cannot be overstated.
  • We hope that this film will raise awareness and understanding of the condition."
  • Minoryx and Neuraxpharm strongly believe that leriglitazone has a positive benefit / risk balance in patients with cALD.