First exercise Flashcards
what did the FDA did to prevent issues during submission process?
1995: pre-investigational device
2013: Premarket approval and Pre-market notification submission
To what was the program change to?
Q-submission Program
what is the objective of the Q-submission Program
it is to manage and track all the interactions between the sponsors and the FDA before their submissions, also the IND and BLA
What does the Q-submission provides?
A mechanism to obtain Feedback from the FDA for future applicantions prior submission
what are the different types of Q-submission?
Pre-submission Submission issues request Study Risk determination Information Meetings Other
Objective in Pre-submission
Feedback from the FDA, specific questions to quide the product development or prepara the submission
Objective Submission issues request
Request feedback from issues of marketing submission to clarify and provide quick solutions.
Objective Study Risk determination
Request information whether the clinical study has a significant risk (SR) or not (NSR) or if it can be exempted from IDE regulation
Objective Information Meetings
Request a meeting for sharing information with the FDA without any feedback
Objective Other
Use to track interactions from premartket approval day 100-Meetings
Agreements and determination meetings
What was the aim of the Obama Freedom of information Act (FOIA)
For FDA to comiited to increase the transparency of their activities
to ensure that the general public understand the FDA’s decisions better
How did FD a provided the commitments form the FOIA?
by creating a task force
the objective of the Phase 1 of the task force
Phase 1: FDA Basics, include information and frequently asked questions
the objective of the Phase 2 of the teask force
Phase 2: constructive dissemination by the FDA. Information about agency operations, decision-making more clear, useful and publicly comprehensible
the objective of the Phase 3 of the teask force
to increase the transparency of the FDA towards the regulated industry
What is the objective of the ombudsman?
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
what is the meaning of supply chain management (SCM)?
it is a variety of actvities to plan,control and execute the product flow of a company
What’s the aim of the SCM?
it is to organize the supple chain in the most economical and efficient way possible
How is the supple chain regulated?
by the legal framework of governments and controlled by their requlatory authorities by aduits and inspections.
what are the comon guidelines for the pharmaceutical SCM?
Drug Supply chain Security Act (DSCSA) by FDA
Good Distribution Practice (GDP) by different publishers (EU, WHO)
What is the Drug Supply chain Security Act (DSCSA)
it is an act to increase the costomer safety by reducing the counterfeiting with authorization of thired-party partners and suppliers
Good Distribution Practice (GDP) is?
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
what should be implemented to avoid misconduct?
a Supply chain Compliance Management System (SCCMS)
What does the SCCMS does?
it is used as a tool to prevent, detect, react to and evalute misconduct in a appropriate manner
what are typical elements of a SCCMS?
Rik assessment, policy framework, supplier qualification, control and monitoring
what are some weaknesses of the pharmaceutical supply chain during this pandemic?
- a high dependence on chian and india (70% of the APS and 50% of the globally needed medicinal product)
- Transportation is highly regulated
- high regulatory requirements and standards
what are the main Impact of Brexit on Drug Regulatory Affairs?
- exit from the EU single market as well as the EU Customs union
- Regulations from the EU and Directice will no longer be applicable to the UK
what happend to the MAH before and after the transition period?
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
how is the situation regulated in cases of reference MP and Generic
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
what has to be aswell transfer regarding the RefMP to the EU
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
what is the consequeunces of a no-deal Brexit?
instents in regulatory non-complaince, supple issues, research and development, QP certification and QC testing
What is the PEI and BfArM?
Paul-ehrlich-institue is the national institue for vaccines and biomedicines.
BfArM: authority in the healthcare operation division focusing on the approval of MP
What is the objective of the PEI
it monitors and evaluates benefits-riks balances of drug products during clinical development, aproval and drug life cycle
The PEI is responsible for?
for Vaccines, antibodies, immunoglobulins
what is BfArM not the responisble for?
for vaccines, biomedinicinal products and veterinary
medicinal prodcuts
What are other tasks for the BfArM?
they do risk analysis, risk assessment and evaluation of medicinal product
what is the task of the BfArM in the pandemic?
-provides continually updated list of antigen test
provide information about different face mask types
How is Vaccine approval in Europe?
it has to show a positive benefit risk assessment, it get market access in the centralized procedure
What are the distributed approaches for MA?
national procedure
mutual recognition procedure
decentralized and centralized procedure
national procedure
MP get access to on specific countries market and guided by the national authority
mutual recognition procedure
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)
decentralized procedure
a pharmceutical company can get access to serval, beforehand chosen markets in EU (CMDh)
centralized procedure
grants market access in all EU countries, coordinated by the EMA and the choes national authorites
which products can be market centrailzed?
products for seriously diseases like HIV and cancer
Approval and monitoring for vaccines in Germany
for a national approval and for the pharmacovigilance the PEI is the resonsible authority
which scope do we have?
mandatory and the optional or generic-hybrid scope
when should the applicant send the pre-submission form for eligibility?
not earlier than 18 months prior to MAA and no later than 7 months before MAA
when is an rapporture appointed?
on confirmation of the submitted plan
3 rapporteur by the CHMP, PRAC and CAT
when should be pre-submission meeting hold?
6-7 months prior to the expected MAA
What is the European Ombudsman?
A crucial role to ensure EMA’s transparency
Who can sent a request to the European Ombudsman?
people, businesses and organiation with in the EU
What else does the Europea ombudsman do?
they check regularly on systemic issues to provide agood administrative practice by means if a strategic plan
what were the issues meantion to the EMA from the European Ombudsman?
EPAR list all relevant pre-submission activites
Publication of clinical data after authorisation
publication of the full risk management plan
EU clincial trails register
why is the pre-submission meeting needed?
they are conducted to discuss the product development, regulatory approval process and legal issus specific to the product of application
How is the transparency of the EMA in pre-submission activites agranteed?
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)
What where some of the key pre-submission activities in COVID-19 therapy?
Fast procedures:
PIP anc rapid complaince check
rapid scientific advice
rooling review
what were the milestone that where accelerated during the COVID-19 procedure?
validation, summary report preparation, pre review, committe discussion, adoption
what was the main objective of the COVID-19 task force?
Manage and coordinate the discussion on development
Assist the CHMP, PRAC and PDCO
represent the CHMP in earyl scientific discussions and products reviws
how does the rapid scientific advice in the COVID-19 therapy carry out?
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
why does the COVID- vaccinces not eligible for orphan drug designation
infections cases is high
