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RAC 2021 > Global Glossary > Flashcards

Global Glossary Flashcards

1
Q

Accelerated Assessment

A

A marketing authorization procedure designed to meet, in particular, patients’ legitimate expectations and take into account the increasingly rapid progress of science and therapies, for medicinal products of major interest from the point of view of public health and in particular from the view point of therapeutic innovation. (EU)

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2
Q

Adulterated

A

Product containing any filthy, putrid or decomposed substance; or prepared under unsanitary conditions; or not made according to GMPs; or containing an unsafe color additive; or not meeting the requirements of an official compendium.

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3
Q

ACTD

A

ASEAN Common Technical Dossier

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4
Q

AHWP

A

Asian Harmonization Working Party

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5
Q

AIMD

A

Active Implantable Medical Device

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6
Q

ALCOA

A

Acronym for key attributes for source documents: attributable, legible, contemporaneous, original and accurate

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7
Q

AMRH

A

African Medicines Regulatory Harmonization

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8
Q

Animal Rule

A

Allows FDA to approve a product for which evidence of
safety and efficacy has been based on data obtained in adequate and well-controlled animal trials. Primarily intended for products that might be unsafe for testing on healthy humans. (US)

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9
Q

Annual Report

A

An annual periodic report or progress report that must be
submitted to FDA. It must include new safety, efficacy and labeling information; preclinical and clinical investigation
summaries; CMC updates; nonclinical laboratory studies;
and completed unpublished clinical trials. (US)

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10
Q

ANSI

A

American National Standards Institute

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11
Q

APEC

A

Asian-Pacific Economic Cooperation

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12
Q

ASEAN

A

Association of Southeast Asian Nations. Comprised of
Brunei Darussalam, Cambodia, Indonesia, Lao PDR,
Malaysia, Myanmar, Philippines, Singapore, Thailand and
Vietnam.

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13
Q

CADTH

A

Canadian Agency for Drugs and Technologies in Health

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14
Q

CAPA

A

Corrective and Preventive Action

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15
Q

CDRH

A

Center for Devices and Radiological Health (FDA)

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16
Q

CE Mark

A

Indicates product conforms with essential health and safety requirements. (EU)

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17
Q

CEN

A

European Committee for Standardisation

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18
Q

CFDA

A

China Food and Drug Administration

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19
Q

CFR

A

Code of Federal Regulations (US)

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20
Q

CIS

A

Confederation of Independent States, comprised of
Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan,
Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan,
Ukraine and Uzbekistan.

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21
Q

CMC

A

Chemistry, manufacturing and controls

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22
Q

Company Core Data Sheet

A

(CCDS) Includes product information relating to safety,

indications, dosing, pharmacology and other information.

23
Q

Company Core Safety Information

A

(CCSI) Contains the core safety data about the product
that is required to be on the product’s label in each country. This safety information is obtained from worldwide case reporting and screening of all product safety information.

24
Q

Competent authority

A

A competent authority is the national governmental authority responsible for the authorization and supervision of medicinal products.

25
Q

Conformity assessment

A

A procedure to enable public authorities to ensure industrial products, including medical devices, placed on the market conform to the requirements as expressed in the provisions of the directives, particularly regarding the health and safety of users and consumers.

26
Q

Crisis management plan

A

Comprises various methods to respond to a crisis and
establish metrics to deal with crises, including defining
what scenarios constitute a crisis and possible response
mechanisms. A crisis management plan should include
possible worst-case scenarios and solutions in the form of a contingency plan.

27
Q

Decentralised Procedure

A

Procedure that may be used for medicinal products for
which there is no existing Marketing Authorisation in any
EU Member State. The applicant can select the Reference Member State and list the Concerned Member States.

28
Q

Declaration of Conformity

A

A document whereby the manufacturer ensures that
either the product safety component satisfies the essential requirements of the applicable directives or the product is in conformity with the type for which a type-examination certificate has been issued and satisfies the essential requirements of the applicable directives. (EU)

29
Q

Directive

A

An EC decision that is binding on EC institutions and
Member States and must be transposed into national legislation. However, the way in which it is implemented is left to the discretion of each Member State. (EU)

30
Q

DMAH

A

Designated Marketing Authorization Holder (Japan)

31
Q

EP checklist

A

A list of Essential Principles indicating their applicability to a particular device and justification for those not considered to be applicable.

32
Q

ERA

A

Environmental Risk Assessment

33
Q

Essential Requirements

A

The technical requirements with which a medical device

must comply in order to be CE marked.

34
Q

EU IVDR

A

New EU regulation for in vitro diagnostic devices. Revises

the EU’s current IVD Directive (98/79/EC).

35
Q

EU MDR

A

New EU regulation for medical devices. Revises the EU’s
current Medical Device Directive (93/42/EEC) and the
EU’s Directive on active implantable medical devices
(90/385/EEC).

36
Q

European Union

A

(EU) The EU is composed of 28 Member States (Austria,
Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, the Netherlands, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden and the UK).

37
Q

EFTA

A

European Free Trade Association, composed of Iceland,

Liechtenstein, Norway and Switzerland.

38
Q

F&DA

A

Food and Drugs Act. Primary law governing medical products in Canada.

39
Q

F&EC

A

Facility and equipment controls

40
Q

FD&C Act

A

Food, Drug, and Cosmetic Act. Primary law governing

healthcare products in the US.

41
Q

Field Safety Corrective Action

A

(FSCA) An action taken by a manufacturer to reduce the
risk of death or serious deterioration in the state of health
associated with the use of a medical device.

42
Q

Field Safety Notice

A

(FSN) A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.

43
Q

FMA

A

Foreign Manufacturing Authorization (Japan)

44
Q

FMEA

A

Failure Mode Effects Analysis

45
Q

GCP

A

Good Clinical Practice

46
Q

GDP

A

Good Documentation Practice

47
Q

GLP

A

Good Laboratory Practice

48
Q

GMP

A

Good Manufacturing Practice

49
Q

Hatch-Waxman Act

A

Enacted in 1984, this act forms the basis for generic drug

approval in the US

50
Q

Health Canada

A

Primary regulatory body for medicinal products in Canada

51
Q

HIPAA

A

Health Insurance Portability & Accountability Act (US)

52
Q

ICF

A

Informed Consent Form

53
Q

ICH

A

International Council on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use (participants include the EU, US, Japan,
Canada and Switzerland)

RAC 2021 (7 decks)

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