imp panel regulations depot storage
TRANSCRIPT
© 2019 Parexel International Corporation / CONFIDENTIAL
IMP – PANEL
Regulations
Depot storageBettina Merz-Nideroest, Dr. Wanda Scherner
7th June 2019
© 2019 Parexel International Corporation / CONFIDENTIAL
Agenda
Drug development and IMP Bettina
Legal regulations on IMPs
ICH-GCP E6R2: responsibilities
Annex 13 GMP: considerations
Depot storage of IMP Wanda
Temperature control
Never events
Supplier qualifications
2
© 2019 Parexel International Corporation / CONFIDENTIAL
Drug Development and
IMP
© 2019 Parexel International Corporation / CONFIDENTIAL4
Drug development
Phase II
Phase IV
drugdiscovery
preclinical studies
clinical studies
marketing approval
© 2019 Parexel International Corporation / CONFIDENTIAL
Medical practice
physicians diagnose and treat patients
status PATIENT
receive „standard of care“: treatments
that hold marketing authorization
minimal risk
documentation for patient and physician
as per standard
5
Medical practice versus clinical research
Clinical research
investigators (specifically trained
physicians) conduct trials to collect data
after voluntary consent → „SUBJECT“
may NOT receive „standard of care“, but
investigational treatments
risk is maybe higher
additional trial-related documentation for
subject and investigator
subject is the ultimate decision-maker
and must have complete information to
assure his/her participation remains
voluntary
© 2019 Parexel International Corporation / CONFIDENTIAL6
Drug development
Phase II
Phase IV
drugdiscovery
preclinical studies
clinical studies
marketing approval
subjects
IMP
medical practice
marketed drugs
© 2019 Parexel International Corporation / CONFIDENTIAL
Legal Regulations on
IMPs
© 2019 Parexel International Corporation / CONFIDENTIAL8
Overview clinical trial regulations
regional
country-
level
international
organi-
zational
WW
guideline
DoH*, GCP*
geographical /
regional regulations:
USA EU
21 CFR directives & regulations: GMP
country regulations
drug law, data protection laws, pharmacy laws, insurance, local requirements
application at organizations: SOPs, manuals, operating guidelines, user guides, etc.
*DoH: Declaration of Helsinki:
set of ethical principles issued
by World Medical Association
*GCP: Good Clinical
Practice: ethical and
scientific standard for
clinical research
© 2019 Parexel International Corporation / CONFIDENTIAL
ICH-GCP E6R2
responsibilities on IMP
© 2019 Parexel International Corporation / CONFIDENTIAL
ICH: International Council for Harmonization: www.ich.org
issues Efficacy, Safety, Quality, Multidisciplinary guidelines, like
GCP: Good Clinical Practice guidelines E6R2
THE international, ethical and scientific quality standard for
designing, conducting, recording and reporting
trials that involve human subjects.
10
ICH-GCP E6R2
© 2019 Parexel International Corporation / CONFIDENTIAL
5.12/13/14 SPONSOR:
information on IMP: ensure sufficient safety and efficacy data is available to support trial
manufacturing acc GMP
IMP coded, labeled, packaged in a manner that protects blinding, acc local regulations
coding systems that permit rapid identification in cases of emergencies
storage conditions
supplying IMP to investigators, when relevant documentation is available, in time
handling instructions
11
Sponsor´s responsibilities
© 2019 Parexel International Corporation / CONFIDENTIAL
4.6 INVESTIGATOR:
→ responsible for IMP at site (can be delegated to pharmacist)
IMP accountability: maintain records of product´s delivery to site, the inventory at site,
the use by each subject and return to sponsor
store as specified
use only acc to study protocol
explain correct use to participants
strictly follow randomization and unblinding procedures
5.18.4 MONITOR main contact between sponsor and investigator
verify storage times and conditions are acceptable, drug accountability, etc.
12
Investigator´s responsibilities
© 2019 Parexel International Corporation / CONFIDENTIAL
EudraLex Vol 4 Annex 13
GMP
© 2019 Parexel International Corporation / CONFIDENTIAL
Good Manufacturing Practice
guidelines that provide minimum requirements that a manufacturer must meet to
assure that their products are consistently high in quality, from batch to batch, for
their intended use.
manufacturing and quality assurance
packaging, labeling, coding
storage and shipment conditions
distribution
quality control, recalls, returns
14
GMP
© 2019 Parexel International Corporation / CONFIDENTIAL
specifications starting materials, packaging materials, intermediate, bulk and
finished product
manufacturing methods, in-process testing and methods, stability data
packaging, labels, blinding operations, randomization codes
technical agreements with contract givers
storage and shipment conditions, shipping
quality control, release of batches
distribution
recalls and returns and destruction
15
GMP considerations
© 2019 Parexel International Corporation / CONFIDENTIAL
handover to Wanda