EPIC and e-learning

roomagitatedInternet και Εφαρμογές Web

8 Δεκ 2013 (πριν από 3 χρόνια και 11 μήνες)

77 εμφανίσεις

EPIC and e
-
learning

An Update……..

Dr Sanjay Kapoor
Medical Affairs Manager
-

Europe

Document Management


The technology and processes which
manage documents and their information
through the creation, assembly, control and
distribution lifecycle


Document Management Issues


A Document is more than a piece of paper


Complex data types with properties (author, drug name, etc.)


Information in documents is difficult to control and distribute


Paper document distribution is costly and delay prone


Document updates are difficult to distribute


Information in documents is hard to find


Locating the desired document is difficult


Quality of information is vital


Must adhere to industry and organizational standards


Must comply with regulatory standards


Publishing is labor
-
intensive


Must create 100,000+ page regulatory submissions


The Solution is EDMS

Provides a controlled

environment allowing

access to data within

an industry that

must adhere to strict

agency guidelines


E
lectronic

D
ocument

M
anagement

S
ystems

Otsuka

s EDMS System

E
lectronic

P
harmaceutical

I
nformation

C
enter


Otsuka’s customized content
management system


Serves as a repository


Designed to
create, edit, review
,
approve, publish

and
track
key
electronic documents related to
the development of a product
.

EPIC is used to…


Control and distribute information within documents


Follow industry, regulatory and organizational standards
for quality of information


Organize many documents for labor
-
intensive tasks, such
as publishing

Creating

Documents

Within Global EPIC, documents can be:


Created within the Docbase


Imported into the Docbase


Copied from an existing document


Scanned into the Docbase

Getting Documents into EPIC

MS Word

Create
with
Templates

Output
from SAS

Scan with
Barcodes

Author or
Import

TEXT

TABLE

CERTIFICATE

Documentum

Repository for
Documents Created
with Existing
Applications

Global EPIC Hierarchy

Cabinet

Highest level of organization for the repository

Contains folders and/or documents

Folder

Contains folders and/or documents

A single document can be in more than one folder, and a single folder can be in
more than one cabinet

Document Type

Compliance etc


GEPIC Desktop Interface

Training…


An example of paper based and e
-
learning

Regulatory requirements for Pharma


General Legal Requirements to Provide
Training in:



Good Clinical Practice (GCP)



Good Manufacturing Practice (GMP)



Good Laboratory Practice (GLP)



Recently, Marketing and Sales legislation that
could be described as Good Sales Practice
(GSP).


Examples of penalties:



$500m failure to comply GMP FDA,
Schering Plough 2002.



$879m violations of the PDM Act (GSP)
FDA, TAP Pharmaceuticals 2002.



£250m (est. losses) flu vaccine
manufacturing suspended by MHRA
GMP violation, Chiron 2004.



$450m violation of the PDM Act (GSP)
FDA, Pfizer 2004.




300m (est. losses) FDA GMP
violations, GSK 2005.


1
2

Pharmacovigilance Training Requirements

Staff should be appropriately trained for performing pharmacovigilance related
activities. *

Training level

Scope

Types of employees

Basic PV training

Company’s legal obligations, how to
recognise and handle a potential ADR or
product quality complaint.

All employees (e.g. receptionists and
Managing Director).

Job
-
specific training

Above + job
-
specific training (e.g.
receipt of ADRs and product quality
complaints by medical information and
referral to drug safety).

Medical information, regulatory affairs,
sales representatives, clinical research
associates and clinical trial
investigators.

*
CPMP compliance statement
-

section 5.3.6 Guideline on Monitoring of Compliance with
Pharmacovigilance Regulatory Obligations and Pharmacovigilance Inspections March
2006.


Legislation

Training for Non
-
Pharmacovigilance Staff


All company employees

are required to understand their responsibilities for
reporting adverse event information to the pharmacovigilance department.


The level of training required will differ, depending on their role within the
Company.


Training provided to non
-
pharmacovigilance staff must be
routinely updated

and
documentary evidence retained

for review by Company or Regulatory
Inspectors.


All employees who have regular contact with customers (e.g. sales
representatives, customer services, medical information, call centre
representatives etc.) must have a documented procedure for forwarding
information on adverse events to the pharmacovigilance department without
delay. Each employee working in such a role must have documented evidence
that they have received training in this procedure.

Topics to be covered


Introduction to Pharmacovigilance
-

Provides employees with an
introduction to the critical concepts, disciplines, and components associated
with pharmacovigilance.


Regulatory Oversight of Pharmacovigilance
-

Familiarises employees with
the scope of regulatory oversight of the pharmaceutical industry with regard to
safety.


Adverse Drug Reactions
-

Provides employees with an overview of the
mechanisms of adverse drug reactions.


Pharmacovigilance Methods
-

Provides employees with a basic
understanding of the methods used to carry out each component of
pharmacovigilance.


Risks Versus Benefits

Familiarises employees with key considerations
affecting risk versus benefits analysis.


Current methods of training


QPP trains the LSM’s on pharmacovigilance procedures
within OFRI and their responsibilities within each affiliates


LSM’s train country employees and thus maintain training
records

QPP

LSM

Staff

A paper based example

Implemented at

OPEL in Jan 2007

Topics covered



Introduction to Pharmacovigilance


A short history of Pharmacovigilance


Aims of Pharmacovigilance


Legislations


Definitions


Individuals responsibilities


How to report an Adverse Event?


Contact Details


Evaluation test


Acceptance Form


Contents

Contents…..

Contents…..

Contents…..

Contents…..

OPEL Product Safety Reporting Form

Contents…..

Contents…..

Contents….

A paper based example

Self Assessment
Questions

Introduction to using the manual

Introduction to Pharmacovigilance

Legislations and definitions

Employees responsibilities

Easy to use flow chart

Acceptance Forms

Otsuka Medicinal Products Information Routing

What is e
-
learning?


Some people call it “
enterprise
” learning, because the
entire organization profits from it.


Others call it “
electronic
” learning, because of its
convenient method of delivery.


Still others see it as “
everywhere
” learning, because it
reaches more people in more locations than has ever been
possible before.


And some call it “
excellent
” learning, because it is
designed to accommodate the individual learner.

E
-
learning


eLearning offers
flexiblity
and
accessibity

-

you can have access to learning
when you want, where you want it and in a way that suits you.


eLearning has removed the
geographical barriers of learning
. It has enabled
organisations to integrate learning with work, recognising the fact that most
learning takes place on the job.


eLearning offers '
just
-
in
-
time
' training opportunities so that you can find out
information, facts, figures, methodologies and learn new skills exactly when
you need to.


eLearning is
cost effective

-

it can help organisations to save money through
improved competencies and skills and reduction in learning times.


eLearning and blended learning bring
numerous unique benefits

to
organisations, employees and customers

E
-
learning Solutions


Convenient
-

access anywhere, anytime from any internet
-
enabled location


Learn at own pace


test knowledge and skills and receive immediate feedback


Expert Content
-

developed by subject matter experts (pharmacovigilance
professionals)


Cost and time


no need to incur travel costs, expensive courses or take everyone
away from their jobs for the day


E
-
learning Benefits


Compliance
-

ensures training is provided within satisfactory timelines and that all
employees, contractors and distributors understand the Company’s
legal obligations and processes.


Evidence of learning
-

provides an audit trail to prove learning.


Training resources
-

relieves the burden of training from pharmacovigilance department.
Easy to update (e.g. new regulations and procedures).


Advantages


Employees can "attend" a course at
anytime, from anywhere


Online learning enables
student
-
centered teaching

approaches


Course material is
accessible 24 hours a day 7 days a week


increases employee interaction



This allows employees to be
exposed to knowledge

that can't be learned in
books


teaches skills in using technologies




Participating online is
much less intimidating

than "in the classroom."


allows for a broad spectrum of content



diversity of course material


Proposed E
-
Learning solutions


Implement a training program that will:


Ensure all and new employees get a harmonised
training


Relieve the burden of training from existing LSMs


Produce an audit trail to prove training


Update existing employees with changing regulations


Easy to use and easy to update


Create an e
-
learning strategy

Need to:


Link e
-
learning goals with business goals


Ensure support from top management


Work with our IT Department to develop an understanding of our
baseline technologies


Work with our IT Department to establish standards for working
together


Determine e
-
learning specifications


Determine how we will measure the results


Prepare a rollout plan

An example

Start Up

Title and Logos

Introduction

Main Menu

Glossary of Terminology

List of Acronyms

Recommended Reading

Module A


Introductions to

ADRs

Module B


Mechanism of

ADRs

Module C


Body Systems in

relation to ADRs

Module D


Reporting ADRs

Process

and Procedures

Module E


Company Specific

Procedures and

Processes

An e
-
learning example

An e
-
learning example

The Knowledge Support Module

42

Unlimited module version updating

43

Development of a Otsuka Learning Management System

This is the Login screen
for the admin portion of
the training system
.

The Administrator options for the
training system are listed here.


There are 3 options:

Administration
”, which allows the
Administrator to perform all functions
from adding new employees and
tests, to assigning tests and
eModules.


Second, is the option for creating new
courses

-

internal training,
scheduling and registration.


Third, is the option to run and view
reports

for SOP testing, Courses and
eModules
.

Development of a Otsuka Learning Management System

This is the screen to
add employees or
contractors to the
database. It is the
beginning of the
process.

Development of a Otsuka Learning Management System

This screen is for adding tests to the
system.


Note that the options for tests are SOP,
WP and G
-
SOP.


Once the test is named, the test
questions are entered and the test is
saved.

Development of a Otsuka Learning Management System

This is the Administrator view
of available tests (SOP, WP,
and GSOP) within the
database
--

active and
inactive.


Once tests are entered,
saved and assigned, this is
the area where they will be
made active, so that users
will have access to the tests.


This is also the area where
superseded tests are
identified.

Development of a Otsuka Learning Management System

An example of a
report showing all
of the tests
required by a
specific functional
area.

Development of a Otsuka Learning Management System

An example of a
report showing the
testing record for a
specific employee.


Note the name and
functional area
designation on the
report.


This relates directly
to the initial
designation when
inputting employee
info into the
database.

Development of a Otsuka Learning Management System

This is a view of the User’s
interface when accessing the
training system. Note that
the drop down menu options
are different from the system
administrator options. “Tests”
allows the employee access
to any SOP/WP tests
determined by the admin for
their particular job function.
The same applies to
“eModules.”


Employees from differing
functional areas may have
different tests and eModules
available to them. “Training
Records” shows a list of all
internal courses taken. ‘

Development of a Otsuka Learning Management System

This is the view
when an employee
selects the “tests”
option on the
database. Any
red
lined

item is
immediately
identifiable as not
taken.

Development of a Otsuka Learning Management System

When an employee
selects an eModule
and begins to review,
this is what the
introductory page
typically looks like.
Note that the related
SOP and WPs are all
listed on the eModule,
since this is a more
comprehensive form of
training. eModules
typically require 30
-
60
minutes of self paced
learning.

Development of a Otsuka Learning Management System

The eModule contains an
evaluation and quiz at the end.
Note, also, the highlighted
components of the eModule, which
would be directly related to the
topics/information within the SOP
and WPs.

View of a question within the quiz
section of the eModule. At the end
of the course and quiz, if 80% (or
determined % for passing) is
achieved, the system prints a
certificate with the user’s name.
This will serve as documentation
of having taken and passed the
eModule.

Development of a Otsuka Learning Management System

Control and Maintenance

Document Creation

Author

Distribution of Copies

Doc Control

Document Formatting

Doc Control

Retain Superseded

Masters and

Destroy Copies

Approval

Retention of Master

HR

QA

MA

FIN

COM

Non Approval

Approved

HR


Human Resources

QA


Quality Assurance

MA


Medical Affairs

FIN


Finance

COM
-

Communications