TransCelerate Q4 Reg Council Quiz

TransCelerate Q4 Regulatory Council Quiz

Test your knowledge about TransCelerate and its initiatives aimed at improving clinical trials! This quiz consists of 10 multiple-choice questions covering various aspects of the organization, its founding, projects, and future vision.

Join us in exploring topics such as:

Founding years and member companies
Work streams and their tools
TransCelerate's mission and vision

10 Questions2 MinutesCreated by CollaborativeMind42

3. This work stream created a toolkit which includes a regulatory landscape assessment which can be used when implementing technologies into clinical trials. This team is also the proud owner of the Shared Insights Knowledge-base, which is a database comprised of member company feedback and lessons learned when implementing technology into a trial.

IGR (Interpretation of Regulations and Guidances)

Patient Technology

QMS

Comparator Network

4. This work stream routinely meets with the NIH to discuss opportunities to make clinical trials more accessible to patients. In fact, they even have a new tool launching in December that aims to improve the quality and patient focus of registration submissions to ClinicalTrials.Gov.

Clinical Research Awareness

Patient Experience

Clinical Research Access and Information Exchange

ESource

7. In 2020 this workstream plans to publish the results of analysis of guidances and regulations across topics such as data privacy and audit trails.

PSoC (Placebo Standard of Care)

IGR (Interpretation of Regulations and Guidances)

ESource

Comparator Network

What is the TransCelerate Mission?

Our mission is to conduct effective advocacy for public policies that encourage the discovery of important, new medicines for patients by biopharmaceutical research companies. To accomplish this mission, we are dedicated to achieving these goals across the country.

To protect and promote the health of the population intervening in the risks associated with the production and use of products and services subject to health regulation.

To collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.

To achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

What is TransCelerate’s vision for the future?

Aspires to create a future state for clinical research where these challenges are no longer roadblocks to success — a vision consisting of healthcare providers (HCPs) that are activated and supporting patients along their healthcare and clinical research journey, where HCPs, sites and investigative staff are fully supported by trial sponsors, researchers have access to the data they need to improve study design, and medications are developed faster for patients in need.

Patients have access to high-quality, safe, and effective medical devices of public health importance first in the world. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.

To be nationally and internationally recognized as an institution that promotes health, citizenship and development, operating in an efficient and transparent manner demonstrating itself as a leader in the field.

Secure the highest level of Excellence in Performance in quality; Maintain a close Partnership with the stakeholders for the common benefit; Actively Contribute to International Harmonization of regulations, guidelines, and standards.

TransCelerate Q4 Reg Council Quiz

TransCelerate Q4 Regulatory Council Quiz

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