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Drug Regulatory Affairs > First exercise > Flashcards

First exercise Flashcards

1
Q

what did the FDA did to prevent issues during submission process?

A

1995: pre-investigational device
2013: Premarket approval and Pre-market notification submission

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2
Q

To what was the program change to?

A

Q-submission Program

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3
Q

what is the objective of the Q-submission Program

A

it is to manage and track all the interactions between the sponsors and the FDA before their submissions, also the IND and BLA

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4
Q

What does the Q-submission provides?

A

A mechanism to obtain Feedback from the FDA for future applicantions prior submission

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5
Q

what are the different types of Q-submission?

A 
Pre-submission
Submission issues request
Study Risk determination
Information Meetings
Other
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6
Q

Objective in Pre-submission

A

Feedback from the FDA, specific questions to quide the product development or prepara the submission

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7
Q

Objective Submission issues request

A

Request feedback from issues of marketing submission to clarify and provide quick solutions.

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8
Q

Objective Study Risk determination

A

Request information whether the clinical study has a significant risk (SR) or not (NSR) or if it can be exempted from IDE regulation

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9
Q

Objective Information Meetings

A

Request a meeting for sharing information with the FDA without any feedback

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10
Q

Objective Other

A

Use to track interactions from premartket approval day 100-Meetings
Agreements and determination meetings

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11
Q

What was the aim of the Obama Freedom of information Act (FOIA)

A

For FDA to comiited to increase the transparency of their activities
to ensure that the general public understand the FDA’s decisions better

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12
Q

How did FD a provided the commitments form the FOIA?

A

by creating a task force

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13
Q

the objective of the Phase 1 of the task force

A

Phase 1: FDA Basics, include information and frequently asked questions

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14
Q

the objective of the Phase 2 of the teask force

A

Phase 2: constructive dissemination by the FDA. Information about agency operations, decision-making more clear, useful and publicly comprehensible

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15
Q

the objective of the Phase 3 of the teask force

A

to increase the transparency of the FDA towards the regulated industry

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16
Q

What is the objective of the ombudsman?

A

charged with the duty of representing and protecting the interests of the public by tackling complaints of maladminitrations and violation of rights and promoting good and ethica administration

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17
Q

what is the meaning of supply chain management (SCM)?

A

it is a variety of actvities to plan,control and execute the product flow of a company

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18
Q

What’s the aim of the SCM?

A

it is to organize the supple chain in the most economical and efficient way possible

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19
Q

How is the supple chain regulated?

A

by the legal framework of governments and controlled by their requlatory authorities by aduits and inspections.

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20
Q

what are the comon guidelines for the pharmaceutical SCM?

A

Drug Supply chain Security Act (DSCSA) by FDA

Good Distribution Practice (GDP) by different publishers (EU, WHO)

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21
Q

What is the Drug Supply chain Security Act (DSCSA)

A

it is an act to increase the costomer safety by reducing the counterfeiting with authorization of thired-party partners and suppliers

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22
Q

Good Distribution Practice (GDP) is?

A

it requires the implementation of a quality system to control the distribution within diffeerent sites and defines rules for third-party auditing as well as documentation

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23
Q

what should be implemented to avoid misconduct?

A

a Supply chain Compliance Management System (SCCMS)

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24
Q

What does the SCCMS does?

A

it is used as a tool to prevent, detect, react to and evalute misconduct in a appropriate manner

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25
Q

what are typical elements of a SCCMS?

A

Rik assessment, policy framework, supplier qualification, control and monitoring

26
Q

what are some weaknesses of the pharmaceutical supply chain during this pandemic?

A
  1. a high dependence on chian and india (70% of the APS and 50% of the globally needed medicinal product)
  2. Transportation is highly regulated
  3. high regulatory requirements and standards
27
Q

what are the main Impact of Brexit on Drug Regulatory Affairs?

A
  1. exit from the EU single market as well as the EU Customs union
  2. Regulations from the EU and Directice will no longer be applicable to the UK
28
Q

what happend to the MAH before and after the transition period?

A

Holder of a MA for MP must be established in the community
At the end of the transition period, a MAH currently established in the UK has to transfer its MA fully to a holder with the EU

29
Q

how is the situation regulated in cases of reference MP and Generic

A

in this cases MA granted before the end of the transtion period referring to a RefMP authorised by the UK remian valid in the EU

30
Q

what has to be aswell transfer regarding the RefMP to the EU

A

Comparator used in a BAS need to be sourced in the EU
Batch control and realse, QP and QP for pharamcovigilance, pharmacovigilance master file should also be transferred to the EU member states

31
Q

what is the consequeunces of a no-deal Brexit?

A

instents in regulatory non-complaince, supple issues, research and development, QP certification and QC testing

32
Q

What is the PEI and BfArM?

A

Paul-ehrlich-institue is the national institue for vaccines and biomedicines.
BfArM: authority in the healthcare operation division focusing on the approval of MP

33
Q

What is the objective of the PEI

A

it monitors and evaluates benefits-riks balances of drug products during clinical development, aproval and drug life cycle

34
Q

The PEI is responsible for?

A

for Vaccines, antibodies, immunoglobulins

35
Q

what is BfArM not the responisble for?

A

for vaccines, biomedinicinal products and veterinary

medicinal prodcuts

36
Q

What are other tasks for the BfArM?

A

they do risk analysis, risk assessment and evaluation of medicinal product

37
Q

what is the task of the BfArM in the pandemic?

A

-provides continually updated list of antigen test

provide information about different face mask types

38
Q

How is Vaccine approval in Europe?

A

it has to show a positive benefit risk assessment, it get market access in the centralized procedure

39
Q

What are the distributed approaches for MA?

A

national procedure
mutual recognition procedure
decentralized and centralized procedure

40
Q

national procedure

A

MP get access to on specific countries market and guided by the national authority

41
Q

mutual recognition procedure

A

after a national market access the expansion to more EU countries, responsible authorities are the coordination group for mutual recongition and decentralized procedure-human (CMDh)

42
Q

decentralized procedure

A

a pharmceutical company can get access to serval, beforehand chosen markets in EU (CMDh)

43
Q

centralized procedure

A

grants market access in all EU countries, coordinated by the EMA and the choes national authorites

44
Q

which products can be market centrailzed?

A

products for seriously diseases like HIV and cancer

45
Q

Approval and monitoring for vaccines in Germany

A

for a national approval and for the pharmacovigilance the PEI is the resonsible authority

46
Q

which scope do we have?

A

mandatory and the optional or generic-hybrid scope

47
Q

when should the applicant send the pre-submission form for eligibility?

A

not earlier than 18 months prior to MAA and no later than 7 months before MAA

48
Q

when is an rapporture appointed?

A

on confirmation of the submitted plan

3 rapporteur by the CHMP, PRAC and CAT

49
Q

when should be pre-submission meeting hold?

A

6-7 months prior to the expected MAA

50
Q

What is the European Ombudsman?

A

A crucial role to ensure EMA’s transparency

51
Q

Who can sent a request to the European Ombudsman?

A

people, businesses and organiation with in the EU

52
Q

What else does the Europea ombudsman do?

A

they check regularly on systemic issues to provide agood administrative practice by means if a strategic plan

53
Q

what were the issues meantion to the EMA from the European Ombudsman?

A

EPAR list all relevant pre-submission activites
Publication of clinical data after authorisation
publication of the full risk management plan
EU clincial trails register

54
Q

why is the pre-submission meeting needed?

A

they are conducted to discuss the product development, regulatory approval process and legal issus specific to the product of application

55
Q

How is the transparency of the EMA in pre-submission activites agranteed?

A

no disclosure of the pre-submission activities during the pre-submission process

the EMa will published after the MA, a European public assessment report (EPAR)

56
Q

What where some of the key pre-submission activities in COVID-19 therapy?

A

Fast procedures:
PIP anc rapid complaince check
rapid scientific advice
rooling review

57
Q

what were the milestone that where accelerated during the COVID-19 procedure?

A

validation, summary report preparation, pre review, committe discussion, adoption

58
Q

what was the main objective of the COVID-19 task force?

A

Manage and coordinate the discussion on development
Assist the CHMP, PRAC and PDCO
represent the CHMP in earyl scientific discussions and products reviws

59
Q

how does the rapid scientific advice in the COVID-19 therapy carry out?

A

the suitability and maturity of the panned request will be reviewed by the COVID-ETF
Upon the dicision, the regular workflow for scientific advice can follow

60
Q

why does the COVID- vaccinces not eligible for orphan drug designation

A

infections cases is high

Drug Regulatory Affairs (15 decks)

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