Several virtual events (webinars, healthcare marketplace, matchmaking meetings) will be held from May 18th to June 28th. You can consult the program here. The upcoming events are:

• June 27th: Webinar: Future for EU-Africa healthcare
• June 27th – June 28th: Matchmaking meetings

The objectives of the series of events are to: 

• Build-up and strengthen the existing relationship between EU and Africa on quality, safe, effective and affordable health products production to address global health needs. 
• Support the research uptake, innovation and manufacturing of vaccines, therapeutics, diagnostics, equipment or other health technologies necessary to prevent and treat diseases particularly prevalent in Africa or relevant for global threats. 
• Enhance the collaboration between EU and African organisations in the value chains of pharma and medical technology industry. 

Registration is free but mandatory and is currently open. Registration closes on June 6th.

More information and registration: https://eu-africa-business-marketplace-matchmaking.b2match.io/

The fully online conference will take place over two days on March 28th – 29th from 13.00 – 18.00 CET.

Registration for the event closes on March 21st.

The conference will allow attendees to interact virtually with a multidisciplinary forum of researchers, clinicians and technology developers, as the community shares collective insight on the genomic basis of rare diseases; strengthening your understanding of human biology, disease mechanisms, and innovative therapeutic approaches. Session topics will focus on:

• Diverse genomes as drivers of precision medicine
• Non-Mendelian forms of rare disease
• Treatment of rare diseases
• High throughput functional assays to improve variant interpretation

More information and registration: https://coursesandconferences.wellcomeconnectingscience.org/event/genomics-of-rare-disease-virtual-conference-20220328/

The webinar will take place on January 18th 2022 from 10.00 – 12.00 CET.

Gaps exist in regulatory science that need to be addressed to improve medicine development and evaluation to enable access to innovative medicines that address patients’ needs. The EMA identified around 100 such topics and will publish them on December 15th 2021 as the “Regulatory science research needs” list.

Thus, this virtual event aims to launch the Regulatory science research needs initiative of the EMA. With this initiative, the EMA seeks to stimulate researchers and funding organisations to consider addressing these needs in their research work and funding programmes, respectively.

Researchers and stakeholders are invited to raise questions and to comment during the event; the agenda can be found here.

More information and registration here: https://ema-europa.webex.com/ema-europa/j.php?RGID=rb39c319843e8c9c7ff344ac294a2bfb1

The fully online conference will take place on November 9, 2021 from 14.00 – 18.00 CET.

This high-level conference will be the occasion to discuss the rare disease ecosystem in its whole spectrum of policies and stakeholders at the national, EU and international level. Starting from a general discussion on how to enable the ecosystem and needs to fulfil, the conference will then develop through three different areas: Research and Development, regulatory approval, and access.

More information and registration here: https://sciencebusiness.net/events/european-rare-disease-ecosystem-collaborative-path-forward

The fully virtual summit will take place over two days from October 18th – 19th.

The summit agenda, which is still being finalised, features several plenary sessions as well as a choice of breakout sessions, on the following themes with both a U.S. as well as an international focus:

• Best Practices and Case Studies for Successful Partnerships
• Rare Diseases as a Public Health Challenge
• Impact of COVID-19 on Rare Disease Research, Clinical Trials and Drug Development 
• Designing Trials for Inclusivity, Equity and Engagement
• Drug Pricing: State and Federal Perspectives
• FDA Patient Engagement
• Gene Therapy and Gene Editing: Current Status and Potential Impact on the Rare Disease Community

More information and registration here: https://nordsummit.org/

You will find the programme here.

Registration is open here.

More information: https://ecogenomics.sciencesconf.org/

On the occasion of Rare Disease Day 2021, Biogen is pleased to invite you to the virtual event: “Unlocking innovation and access for rare disease patients in Europe” taking place on Monday, 22 February from 14:00 to 15:45 CET. Biogen’s event, done in collaboration with Reuters and EU40, will highlight the need for continued political leadership and action to improve care for rare diseases patients in Europe.

In the build up to the event, we are also launching a social media campaign under the hashtag #icare4rare with various personalities and stakeholders delivering their message about rare diseases and what the EU institutions can do to support innovation and access for patients with rare diseases. You can find all information here in case you are interested in participating or sharing with your network.

For the event, registration is open here and agenda attached, and we really hope to have you there.

To learn more about other activities relevant to rare diseases and listen to stories from the rare disease community and FDA staff working on rare diseases, please visit this webpage.

CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single-entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.

To facilitate preparedness for use of CTIS (Clinical Trials Information System-the tool that will centralise the regulatory submission for multinational clinical trials in Europe) the European Medicines Agency has developed a training programme to provide future CTIS users with the skills and knowledge to successfully use CTIS into their business.

There are two training sessions targeted to SMEs and academia trial sponsors:

Day 1 on 22^nd February 2021 will present CTIS access management, user management and different roles in CTIS.

Day 2 on 4^th March 2021 will focus on CTIS functionalities – how to submit and manage a clinical trial application. Transparency of reporting of results will also be presented on Day 2.

The webinar will include presentations by speakers from EMA system experts and presenters from SME and academic institutions, demonstration of the system, and opportunities for questions and answers. The webinar will be recorded and published for future perusal.

To express your initial interest for this training, please complete the expression of interest questions by the 29^th of January 2021.

More information on the training event can be found here