Glossary

Discover full dictionary

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510 K
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Accountability
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Accuracy
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Ad-Hoc Services
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Adequacy decision
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Adverse event
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Analysis data model (ADaM)
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Anonymization
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Appropriate safeguards
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Article 29 Working Party
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Artificial Intelligence
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Automated individual decision
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Auxiliary medicinal product
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Best-in-class drugs
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Binding corporate rules (BCR)
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Biometric data
B
Biotechnology
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Central Laboatory
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Central imaging
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Chemistry, Manufacturing, and Controls (CMC)
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Term of the Day

Informed consent

Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.

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Automated individual decision

An automated individual decision is a decision which significantly affects a person and which is based solely on automated processing of personal data in order to evaluate this person. Such an evaluation may relate to different personal aspects, such as performance at work, creditworthiness, reliability, conduct, etc.

Article 22 of Regulation (EU) 2016/679 and Article 24 of Regulation (EU) 2018/1725 lay down the right for individuals to object to decisions about them and solely based on automated means, unless certain conditions are fulfilled or appropriate safeguards are put in place.

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