Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

Reg Affairs > L2 Rules for Engagement > Flashcards

L2 Rules for Engagement Flashcards

1
Q

Define Drug.

A

Any substance, other than food, that when inhaled, injected, smoked, consumed, absorbed via a patch on the skin or dissolved under the tongue causing a physiological change

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Define medicine.

A

Substance used to treat, cure, prevent, diagnose a disease or promote well-being

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is the drug substance/API/IMP?

A

Pharmacologically active ingredient

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What is the drug product?

A

Full pharmaceutical product in final form - contains APIs & excipients

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is an excipient?

A

non-API components of a finished medicinal drug product included to facilitate manufacture, stability, control release of API, or other characteristics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is a novel drug/NCE/New Biologics?

A

Any drug where the composition is not generally recognized as safe & effective among experts

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What 3 things are also included in the new drug definition?

A

major changes in formulation/manufacturing
New fixed dose combo of approved drugs
New route of admin

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is a regulatory agency?

A

Competent authority is any person or organization that has legally delegated or invested authority, capacity or power to perform a designated function

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is the Sponsor?

A

Entity that will ultimately market the product, take responsibility for writing the marketing approval applications
eg. company

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are the investigators?

A

People on the ground conducting clinical trials

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

what are 3 regulatory instruments?

A

Laws - written statutes
Regulations - standards & rules
Guidance - documentation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What are cons of the global regulatory landscape?

A

Different territories have developed different licensing procedures, regulatory requirements & approval processes - anti-innovation & anti-business

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What must all medicines marketed, distributed & used in a country be?

A

Registered with national competent regulatory authority

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is the main submission for licensing/market authroisation?

A

Marketing Authorisation Application

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What are 4 primary issues to be addressed for marketing authorisation?

A

Is the drug safe & effective?
Do benefits outweigh risks?
Are manufacturing methods & controls adequate to preserve identity, strength, quality & purity?
Is proposed labelling & accompanying info appropriate?

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What does the Totality of Evidence comprise of (6 things)?

A

Chemistry/Quality Review
Pharma/toxic review
Medical/clinical review
Biopharma review
Stats review
Proposed labelling review

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What 4 pieces of evidence is supplied with the MAA?

A

audits
inspections & approvals
engaged CROs
clinical trial sites

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What is a Dossier?

A

Collection of documents/files containing all technical data relating to proposed medicinal product

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What is an early developmental document?

A

Investigators Brochure

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What are the Clinical Development documents?

A

EU - IMPD
US - IND/DMF

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What is the document for licensing approval?

A

Common technical document - accepted by all major medicine regulatory authorities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

What are the 5 benefits of the CTD?

A

Reduce time & resources
Ease of prep
Facilitate reviews
Improves communication
Simplify exchange of info

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

What is module 1 in CTD?

A

Regional specific info

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

What is module 2 in CTD?

A

overviews & summaries - quality, non-clinical & clinical

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
What is module 3 in CTD?
Quality (manufacturing, control methods, analytical tests)
26
What is module 4 in CTD?
Pre-clinical investigations (in vitro, in silico & animal models)
27
What is module 5 in CTD?
Clinical Investigation (phases I-III)
28
If you want to change the CTD who do you go to?
ICH
29
What 3 levels can regulation occur at?
National level Federal level Regionally by multiagency body
30
What are characteristics of decisions?
Decisions come from court within EU - once made & published it is immediately legally active in all EU states eg. Working time directive
31
What are characteristics of directives?
Each country has a period of time to pass local legislation to bring main elements of law in
32
What are characteristics of regulations?
Regulations have same power as decisions - as soon as it is brought in it is legal
33
What is the EMA?
Decentralised scientific agency of the EU Not a regulatory authority
34
What are 4 responsibilities of the EMA?
Assessment of centralised procedures Evaluation & supervision of medicines Co-ordination of EU networks Role in stimulating innovation & research
35
Who issues licenses for drugs?
EC
36
What are all parties in the EMA linked by?
IT network called EudraNet
37
How many scientific committees are in the EMA?
7
38
What does the EU network for scientific advice & expertise constitute of?
27 EU member states > 40 comptenet authorities 4,500 european experts
39
What is the EMA not responsible for (8 things)?
Licensing Evaluation of all medicines Advertising of medicines Research of medicines Price & reimbursement Clinical trial approval Medical devices EU health care policies
40
Who are EMA committee members nominated by?
NCAs of EEA Member states
41
What is the CHMP comprised of?
27 MSs + NO/IS 1 scientific expert nominated by NCA & 1 alternate 5 co-opted members appointed by Management board
42
Who are the observers of the CHMP?
Norway & iceland
43
What is the centralised procedure?
Regulatory review process
44
What 4 things are part of the centralised procedure?
1 marketing authorization 1 invented name 1 common labelling defined time to decision
45
Who does the primary assessment?
Rapporteur & co-rapporteur
46
What is the centralised procedure reserved for?
Innovative products in priority disease areas
47
What is the centralised procedure not suitable for?
Existing medicines in non-priority indications eg. aspirin for headache
48
If products are eligible for the CP where is this defined?
Legislation Annex to Regulation (EC) 726/2004
49
What are priority areas for CP?
HIV/AIDs Cancer Diabetes NGD Auto-immune Viral disease
50
What 4 types of medicines have to go through CP?
From biotech processes Advanced therapy medicinal products Orphan Medicinal products Vet medicines for use as growth or yield enhancers
51
What is the CP optional for (3 things)?
Completely new active substance significant therapeutic or innovation Interest in public/animal health at EU ;level
52
What is the Mutual Recognition Procedure?
Existing national authorisation issued by one NCA will be recognised by up to 26 other national reg authorities in EEA
53
What is the decentralised procedure?
Collaborative Evaluation at MS level without any pre-existing national MA
54
What is the aim of the decentralised procedures?
Obtain simultaneous approval in subset of EEA By CMDh
55
How is FDA different to EMA?
Do award licenses - regulatory agency EMA do not do any laboratory testing
56
What is the FDA mission staement?
Responsible for protecting public health by assuring safety, efficacy & security of human & vet drugs, bio products, medicinal devices, food supply, cosmetics & products that emit radiation
57
How does the FDA advance public health?
Helping to speed innovations that make medicines & foods more effective, safer & affordable
58
What does the FDA CDER regulate?
Drugs (small molecules) & some biologics eg. mAbs
59
What does the FDA CBER regulate?
Biological products eg. vaccines, gene therapy
60
What does the FDA CDRH regulate?
Access to safe, effective & high quality medicinal devices & safe radiation-emitting products
61
When is an IND filed to the FDA?
End of a successful preclinical development program for a new drug
62
What is the IND?
Procedure to obtain permission to conduct clinical studies with investigational drug
63
What is the primary objective of the IND application?
Protect clinical trial subjects from unnecessary risks
64
What does IND filing increase?
Monetary value of IP
65
What is an NDA?
Application for approval to market of a new drug in US
66
What is a BLA?
Application for approval to market of a new biologic in US
67
What is the ANDA?
For generic drugs which do not require a full clinical development program
68
What is the ICH?
Joint initiative involving both regulators & research-based industry reps
69
What is ICH's mission?
Make recommendations towards achieving greater harmonisation in interpretation & application of technical guidleines & requirements for pharma product registration
70
What does ICH reduce?
Duplication of testing carried out during research & development of new human medicines
71
What are ICH's objectives (5)?
Increase international harmonisation Harmonize technical requirements for registration Develop & register pharmaceuticals efficicently Promote public health Minimize animal testing
72
What are 4 ICH activity categories?
New guideline topics under development Existing topics under revision Existing topics under maintenance Existing topics needing clarification for implementation (Q&A)
73
How many ICH guidelines are there?
Over 50
74
What do each regulating body usually publish?
Their own specific guideline documents which clarify their particular stance on each area/topic

Reg Affairs (11 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions