IMP PANEL Regulations Depot storage

© 2019 Parexel International Corporation / CONFIDENTIAL

IMP – PANEL

Regulations

Depot storageBettina Merz-Nideroest, Dr. Wanda Scherner

7th June 2019


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


Drug Development and

IMP

© 2019 Parexel International Corporation / CONFIDENTIAL4

Drug development

Phase II

Phase IV

drugdiscovery

preclinical studies

clinical studies

marketing approval


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


Drug development

Phase II

Phase IV

drugdiscovery

preclinical studies

clinical studies

marketing approval

subjects

IMP

medical practice

marketed drugs


Legal Regulations on

IMPs


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


ICH-GCP E6R2

responsibilities on IMP


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

http://www.ich.org/


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


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


EudraLex Vol 4 Annex 13

GMP


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


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


handover to Wanda

Documents

IMP PANEL Regulations Depot storage