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The EMA’s Management Board met on 5 October in Amsterdam. The article below covers the highlights discussed in the meeting, including:

• Clinical trials in the EU
• Mid-year report 2023
• EMA HR Strategy
• Covid-19

Read in full here.

The MHRA have recently launched a new notification scheme, the first step in their overhaul of the clinical trials regulations

The notification scheme enables a more streamlined and risk-proportionate approach to processing Clinical Trial Authorisation for “initial” applications.

This new scheme only applies to Clinical Trial Authorisation applications for Phase 4 and certain Phase 3 clinical trials deemed to be of lower risk; it does not include Clinical Trial Authorisation applications for first in human (FIH), Phase 1 or Phase 2, or amendments at this time.

For more information, visit their website here.

You can also watch a video from the MHRA on their LinkedIn here, where Deputy Director of Clinical Investigations and Trials, Andrea Manfrin, explains which trials are eligible for the scheme and the criteria for the trials.

The ACDM: Association for Clinical Data Management is delighted to welcome Mednet as a new corporate member.

Mednet is a healthcare technology company specializing in eClinical solutions designed for the global life sciences community. Mednet’s comprehensive, EDC-centric eClinical platform improves the efficiency of clinical studies of all types and sizes. Beyond electronic data capture (EDC), Mednet’s solution set provides the tools required to build and manage all types of clinical research, while enabling organizations to adapt to evolving demands and requirements. Pharmaceutical, medical device, biotechnology and Contract Research Organizations (CROs) around the world have trusted Mednet for nearly 20 years to deliver the technology innovation, experience and reliability they need for success.

Members gain many benefits from membership, including:

• Access to training courses at a discounted rate
• Assign full ACDM membership to all individuals within your organisation
• Place an organisation profile, description and logo on the ACDM website
• Advertise jobs for your positions within your organisation
• Reduced price attendance at conferences and symposia
• Free attendance at Hot Topics

Find out more about becoming a corporate member here.

The ACDM: Association for Clinical Data Management is delighted to welcome Allucent as a new corporate member.

Allucent is a Contract Research Organisation that focuses on small and mid-sized biotech. Designed to serve smaller companies, Allucent offers capabilities and expertise that mirror those of larger CROs, but delivered with a more personal and flexible style tailored for the client. Working collaboratively, Allucent stays close to the science that drives therapeutic innovation.

Members gain many benefits from membership, including:

• Access to training courses at a discounted rate
• Assign full ACDM membership to all individuals within your organisation
• Place an organisation profile, description and logo on the ACDM website
• Advertise jobs for your positions within your organisation
• Reduced price attendance at conferences and symposia
• Free attendance at Hot Topics

Find out more about becoming a corporate member here.

The ACDM: Association for Clinical Data Management is delighted to welcome KCR as a new corporate member.

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US; Berlin, Germany; and Warsaw, Poland. Their geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies.

Members gain many benefits from membership, including:

• Access to training courses at a discounted rate
• Assign full ACDM membership to all individuals within your organisation
• Place an organisation profile, description and logo on the ACDM website
• Advertise jobs for your positions within your organisation
• Reduced price attendance at conferences and symposia
• Free attendance at Hot Topics

Find out more about becoming a corporate member here.

The ACDM: Association for Clinical Data Management is delighted to welcome Debiopharm as a new corporate member.

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to improve patient outcomes and quality of life in oncology and bacterial infections. Their main activities include drug development, drug manufacturing and digital health investment.

Members gain many benefits from membership, including:

• Access to training courses at a discounted rate
• Assign full ACDM membership to all individuals within your organisation
• Place an organisation profile, description and logo on the ACDM website
• Advertise jobs for your positions within your organisation
• Reduced price attendance at conferences and symposia
• Free attendance at Hot Topics

Find out more about becoming a corporate member here.