Location

Clinical Trials Information System (CTIS) Bitesize Talk: How to submit a transitional trial in CTIS, Online, Broadcast, from 29 February 2024, 16:30 (CET) to 29 February 2024, 18:00 (CET)

Retrieved on: 
Tuesday, April 23, 2024
SME, Location, CTIS, European Economic Area, Transition, Clinical trial, European, EMA

This bitesize talk on CTIS provides an opportunity for sponsors to learn how to create and submit transitional trials in Clinical Trials Information System (CTIS).

Key Points: 
  • This bitesize talk on CTIS provides an opportunity for sponsors to learn how to create and submit transitional trials in Clinical Trials Information System (CTIS).
  • Sponsors will also have the opportunity to ask questions on this CTIS topic before and during the event.
  • The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.
  • Please subscribe to the clinical trials newsletter for updates on the availability of CTIS event video recordings.

SPOR Status Update, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 July 2024, 10:00 (CEST) to 10 July 2024, 12:30 (CEST)

Retrieved on: 
Friday, April 19, 2024
SMS, Location, RMS, OMS, IRIS, EMA, RDM

Date

Key Points: 
  • Date
    - Wednesday, 10 July 2024, 10:00 (CEST) - 12:30 (CEST)
    Location
    - OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive Broadcast
    Event summary
    EMA is organising a public webinar on Substance, Product, Organisation, Referentials (SPOR) Regulatory Data Management (RDM) services status update.
  • SPOR RDM services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, efficiencies and more efficient regulatory action.
  • Through the integration of its services with other systems used for regulatory procedures, such as IRIS, SPOR actively contributes to their success and full benefits realisation.
  • SMS, XEVMPD/Art.57, OMS, and RMS) will be provided:
    - Achievements in Q2 2024.

Network Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 June 2024, 10:00 (CEST) to 18 June 2024, 11:30 (CEST)

Retrieved on: 
Friday, April 19, 2024
VNRA, Location, Product lifecycle, Marketing, UPD, RPM, Regulation, PLM, Risk management

The webinar will also include a live demonstration of the Network Portal, enabling participants to discover the new features and functionalities developed.

Key Points: 
  • The webinar will also include a live demonstration of the Network Portal, enabling participants to discover the new features and functionalities developed.
  • Do not miss this valuable opportunity to enhance your understanding and stay informed about the latest developments in this area.
  • The products for this roll-out have been selected by reviewing the intended submission plans from the selected MAHs, who have received already the final list of products.
  • In this regard, a 2nd roll-out will be performed in Q4 2024.

Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRI, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 June 2024, 10:00 (CEST) to 13 June 2024, 11:30 (CEST)

Retrieved on: 
Friday, April 19, 2024
VNRA, Location, Product lifecycle, Marketing, UPD, RPM, Regulation, PLM, Risk management

The webinar will also include a live demonstration of the Industry Portal, enabling participants to discover the new features and functionalities developed.

Key Points: 
  • The webinar will also include a live demonstration of the Industry Portal, enabling participants to discover the new features and functionalities developed.
  • Do not miss this valuable opportunity to enhance your understanding and stay informed about the latest developments in this area.
  • The products for this roll-out have been selected by reviewing the intended submission plans from the selected MAHs, who have received already the final list of products.
  • In this regard, a 2nd roll-out will be performed in Q4 2024.

Paediatric Oncology Strategy Forum: 24-25 October 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 October 2024 to 25 October 2024

Retrieved on: 
Friday, April 19, 2024
Malignancy, Acceleration, Science, Location, Cancer, EMA, European Medicines Agency, FDA, Food, Pharmaceutical industry

The goal of these meetings is to share information, to facilitate the development of innovative medicines and ultimately their introduction into the standard-of-care of children with malignancies.

Key Points: 
  • The goal of these meetings is to share information, to facilitate the development of innovative medicines and ultimately their introduction into the standard-of-care of children with malignancies.
  • Participation is restricted and by invitation only.
  • It will be a 'hybrid' meeting, taking place at EMA in Amsterdam and also online.
  • A meeting summary and scientific publication will result from the forum.

Focus group on veterinary pharmacovigilance reporting in aquaculture, European Medicines Agency, Amsterdam, the Netherlands, from 22 November 2023, 10:00 (CET) to 22 November 2023, 17:00 (CET)

Retrieved on: 
Thursday, April 18, 2024
Focus, Aquaculture, Veterinarian, Pharmacovigilance, Location, European Medicines Agency, Public, Knowledge, Agency, Environment

Date

Key Points: 
  • Date
    - Wednesday, 22 November 2023, 10:00 (CET) - 17:00 (CET)
    Location
    - European Medicines Agency, Amsterdam, the Netherlands
    Event summary
    The European Medicines Agency has a coordinating role in the EU pharmacovigilance system and operates services and processes to support veterinary pharmacovigilance activities.
  • This entails surveillance of adverse events, including lack of expected efficacy reported after veterinary medicinal products are used in practice, to safeguard animal and public health and the environment.
  • The Agency is hosting a Focus group meeting for veterinarians or other healthcare professionals on facilitating pharmacovigilance reporting of medicinal products used in aquaculture.
  • Registration
    Attendance is by invitation only.

Cancer Medicines Forum: February 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, 26 February 2024

Retrieved on: 
Thursday, April 18, 2024
Location, Cancer, EMA, CMF, Vaccine

Date

Key Points: 
  • Date
    - Monday, 26 February 2024
    Location
    - OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
    Event summary
    The Cancer Medicines Forum (CMF) aims to explore how EMA can contribute towards addressing remaining uncertainties about the use of cancer medicines in clinical practice.
  • The forum brings together representatives of academic organisations from EMA’s Healthcare Professionals Working Party and the European medicines regulatory network.
  • The results of discussions will support the prioritisation of actions to fight cancer in EMA's Regulatory Science Strategy to 2025 and Academia Collaboration Matrix Action Plan.
  • The meetings of the forum are by invitation only.

EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2024, 13:00 (CEST) to 17 April 2024, 16:00 (CEST)

Retrieved on: 
Thursday, April 18, 2024
Patient, Location, Mental health, Medical device

Date

Key Points: 
  • Date
    - Tuesday, 16 April 2024, 13:00 (CEST) - 18:00 (CEST)Wednesday, 17 April 2024, 09:30 (CEST) - 16:00 (CEST)
    Location
    - OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive Broadcast
    Event summary
    This multi-stakeholder workshop will bring together patients, healthcare professionals, academia, regulators, and industry to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.
  • The aims of the workshop are to:
    - Hear the views of stakeholders and experts on the therapeutic potential of psychedelics;
    - Provide further clarity on defining the safe and effective use of psychedelics;
    - Inform on regulatory challenges associated with the development and evaluation of psychedelic medicines;
    - Define areas for which further regulatory guidance is required.
  • The workshop will be broadcast live and the recording will be made available after the event.

EMA traineeship programme informative session, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 23 April 2024, 10:00 (CEST) to 23 April 2024, 11:00 (CEST)

Retrieved on: 
Thursday, April 18, 2024
Location, European Medicines Agency, EMA

Date

Key Points: 
  • Date
    - Tuesday, 23 April 2024, 10:00 (CEST) - 11:00 (CEST)
    Location
    - OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive Broadcast
    Event summary
    Would you like to know what are the requirements to apply to a traineeship at EMA?
  • How is the selection process?
  • What to expect if you are selected?
  • Join this information session and learn how to apply to the EMA traineeship, eligibility requirements, steps on the selection process and practical aspects of being a trainee at the European Medicines Agency.

EMA/FVE info session on restrictions for the use of certain antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 May 2024, 15:00 (CEST) to 23 May 2024, 16:00 (CEST)

Retrieved on: 
Thursday, April 18, 2024
Location, Public, Regulation, EMA, Human, Risk, AMR, Science, Veterinarian, Agency, WHO, Animal, Cisco Webex, Vaccine

During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.

Key Points: 
  • During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.
  • Registration
    Please register for the webinar using the below online form:
    EMA/FVE info session on restrictions for the use of certain antimicrobials in animals
    Please note this event will be recorded and published on the EMA website.
  • By registering for this event, you are consenting to EMA to process your personal data in accordance with Regulation (EU) 2018/1725.
  • EMA's data protection notice below explains how personal data is processed by the Agency and via the tool Webex: