Clincial trials regulation livia

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  • Created by: Amh
  • Created on: 13-04-17 09:51
what were pharmacopoeias
(old timey regs) The requirements for the qualitative and quantitative composition of medicines • The tests to be carried out on medicines, substances, or materials
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what is the ICH
The international counsil of harmonisation
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what does ICH do
network of erg authorities and pharmaceutical professionals who want to achieve greater harmonization worldwide to ensure safe effective and high quality medicines are developed and registered
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When are regulatory affairs impactind on product life cycle
in the development stage, in the approval phase, in the post approval stage
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Why are regulatory requirements involved in the development phase
Need to ensure legisltive requirements are me, arrange for scientific advice from authorities, advice on dev studies to demonstrate efficacy and saftey, set up a reg strategy, ensure application guidlines, preparatio and management of submission
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Why are regulatory requirements involved in the development phase pt 2
minimise time to market, advise on global stratagy, optimise submission stratagy, dossier prep, electronic submsission, commercial side
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what are high level documents
• Documents that include data and files to be submitted with • Non-clinical, quality and clinical overview • Introduction to the data with a critical assessment of the results • Justifies deviations from guidelines • Justifies development and testing
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whata re the roles of reg affair in apporval phase
Check progress of evaluation and anticipate questions (prepare answers) • Clarify raised questions, plan response, strategies with other departments • Plan and manage agency meetings/hearings • Negotiate approval and product information with agencies
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how long does marketing authorisation last
5 years
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what are the roles of reg affair in post approval phase
compliance, • Submission of variations/amendments • Renewars • Pharmacovigilance • Product information review • New indications/new formulations- input to development plans • Regulatory Intelligence
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what is ctd
• Common Technical Document (CTD) – standard format used for marketing authorization applications • Common agreed structure for the main sections (safety, quality, efficacy) of regulatory submission`
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what is regularoy intelligence
a systemic process initiated by a defined need, • It is a collection of data and analysis of the data linked to a strategy looking at the other products on the market
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what is the clinical trials directive
Laws, regulations and administrative provisions 4 the implementation of Good Clinical Practice. • It’s an EU directive • Aimed at:Facilitate internal market of medicinal products • Maintain appropriate level of protection for publlic service
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whats in the clinical trialsdirective
definitions, protection of clincial trial subjects, consent, ethics comittee, guidance, conduct, commencement of a trial, exchange of info, labelling, manufacturing and importation. adverse effects
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what was the effect of the clinical trials directinve
increased the costs of doing clinical trials in the EU • Reduced numbers of such trials (academic-led, and repurposing) • Germany derogated from the directive • It was replaced by the EU Clinical trials Regulation in 2016 (changes in 018)
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what is GCP
Good clinical practice: • A set of internationally-recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials
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Where is there fuidance on gcp
(CTD) and ICH: • GPC follows International Conference on harmonization of technical requirements for registration of pharmaceuticals for human use of GCP guidelines.
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Where are some of these high standards of practise imposed
-comprehensive documentation for clinical protocol -record keeping - Training - Facilities - Computers - softwares
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what are the aims of good clinical practise
1. studies aer scientifically authentic 2. clinical properties are properly documented 3. includes protection of human rights for patients and volunteers 4. provide saftey and efficacy assurance of newly developed compound
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who should follow gcp
sponsors, slinical research investigators, and monitors
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What are the problems with gcp
• GCP been called ‘a less morally authoritative document’ compared to the Declaration of Helsinki • Public disclosure of study design • Benefit for populations in which research is conducted • Reporting of accurate results and publication of negative
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what is a clinical trials registry
Official platform and catalog for registering a clinical trial • Not required for all countries, but strongly encouraged • Clinicaltrials.gov – first online registry for clinical trials
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what is the goal of clin trial registry
To provide increased transparency and access to clinical trials made available to the public. • Registries are searchable (disease/indication/drug/location etc) • Registered by pharmaceutical, biotech, medical device company, hospital or contract re
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why register clinical trials
remove reporting bias, so that not only positive findings are published, wthical interests
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Card 2

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what is the ICH

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The international counsil of harmonisation

Card 3

Front

what does ICH do

Back

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Card 4

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When are regulatory affairs impactind on product life cycle

Back

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Card 5

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Why are regulatory requirements involved in the development phase

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