Agenda · 2020-05-04 · Agenda • Introduction to TOM • Impact of TOM • Current milestones...

Agenda

• Introduction to TOM

• Impact of TOM

• Current milestones and deliverables

• Prioritization of activities

• Discussion of questionnaire results

• Planned roadmap vs reality

• Use cases

• Questions and Discussion

Confidential – IPERION® 2020 2

Introduction to TOM


Why are we here?


IDMPxEVMPD

New legislation requires

Develops SPOR as the vehicle

Current Status

WIP

A need to develop the PMS TOM

IhaveaDreaMP

Structured data for either

RA, PhV, QA, clinical,

manufacturing information

Data is captured and

submitted only once

MAA,

variation, renewal,

ICSR,

CTA

How to achieve the dream→ work on

Target Operating Model (TOM)

The need for common product data


RIMs

MAH1

MAH2

MAH3

MAH4

NCA1

NCA3NCA2

Regulators

NCA4

EMA

NOW:

MAHsApplication

Approval

1

23

4xEVMPD

xEVPRM

Article 57

No single source of truth & No involvement of the relevant NCA during xEVMPD submission

Future Single EU database


EMA central

databases

PMSHuman&VET

NCA1

NCA3NCA2

Regulators

NCA4

EMA

MAHsApplication Data Set

(Procedure and Product Data)

1

Future:

✓ Data submission, validation,

assessment and approval as part

of regulatory process, resulting in

trusted/qualified data

✓ Applicant responsible for

updating the data

2

Assessment & Approval

3

Enrichment of Product Data

One time exchange & Single source of truth

TOM – Targeting Operating Model


TOM is needed to optimise the exchange of application data between regulators

and applicants, and within the regulatory network to ensure data quality.

Defined processes in which

data is submitted, validated,

assessed and approved

Defined message exchange

format

Defined way of working

between regulators and

industry

Product

Data

Qualified

Product Data

Expectations of TOM


Support

• All procedure types (CP, MRP, DCP, NP), discussion to start with CP

• The re-use of data for PMS and NCA/EMA databases

• The re-use of existing technology frameworks for implementation

Enables

• The sharing of workload in the regulatory network and must consider specifics (such as MRP/DCP/Worksharing, etc.)

Can be

• Introduced in the short term without triggering big changes in the regulatory processes

• Used in both human and veterinary domains

Require

• Minimum requirements for NCAs/EMA and applicants (keep it simple!)

• Commitment to develop and implement the TOM

• The network to start using SPOR data

Impact of TOM


The way information is

captured and used will

change

The messaging format

in which product data is

exchanged will change

Increased responsibility

and collaboration for

product data

management

Current process in

which data is managed

and exchanged will

change

ProcessP

Impact of TOM


OrganizationO TechnologyT InformationI

Procedure and Product

data ready for

submission

• Organizations,

Referentials and

Substances data

ready in SPOR

• Product data

structured in

accordance to EU IG

• Relevant product

data sourced from

relevant systems

• The message

exchange format

embedded

• New process

owners

• New roles and

responsibilities

assigned

• Governance in

place (i.e. data,

processes,

systems)

• New process to

facilitate the

preparation of

procedure and/or

product data for

submission

• New process to

facilitate

interactions

between regulators

and industry

How does that look like?


NOW: Future:

Product data submission goes from post-approval to pre-approval

ProcessP OrganizationO TechnologyT InformationI

What are the concrete changes?


ProcessP OrganizationO TechnologyT InformationI

Develop Apply Market ConsumptionApproved

• Data needs to be

collected earlier

• Establish data

governance

• Pre-register and

align with SPOR

• Systems integration

• Write new SOPs

Employees need to be

trained:

• New SOPs

• SPOR usage

• IDMP

• New Tools

• Integrate new tools

for collecting and

managing data

• Develop interfaces

for system

integration

• Implement

messaging formats

for data exchange

Data needs to be:

• Collected

• Mapped

• Cleansed

• Structured

• Stored

Current Milestones and Deliverables


Planned Milestones and Deliverables


RMS live: start mapping

OMS live: start mapping

SMS live: start mapping

EMA

XEVPRM

EU IG v2Published

12m

PMS It.1Go Live

PMS It.1Enforcement*

NCAs

CESP Phase 2*UNICOM

NCAs assess Product Dataset during the Procedure (MRP/DCP/NP) via eAFwith a transition period

EMA assess Product Datasetduring the Procedure (CP)

Q4 2020

TransitionComplete

STEP 1 STEP 2

Q4 2021 Q4 2022 Q4 2023 TBD

12m 12m*

EU IG v3

*enforcement scope/modalities TBD

• Submission of product

data post-approval

• Assessment by EMA


data in procedure for CP


data post approval for

non-CP

• Assessment by EMA


data in procedure for all

procedures

• Assessment by NCAs

Prioritization of Activities


Establish system integration & embed messaging format

Industry Activities 2020-2021 to realize the plan


Mapping of organization information to OMS

Mapping of master data to referentials in RMS

Mapping of Substance information to SMS (EU-SRS)

Preparation for Initial PMS submission

• Identify internal data

sources, owners and

systems

• Collection of data and

relevant documents

• Map internal

organization data to

OMS

• Create or update

organization data in

OMS if needed

• Identify data sources,

owners and systems

• Collection of master data

• Map master data with

referentials in RMS

• Request new and

updated referentials lists

and terms in RMS if

needed


owners and systems

• Collection of

substances, including

definition and description

• Map internal substances

data to SMS

• Create and update

substances in SMS if

needed

• Identify required data

elements as stated in

EU IG


owners and systems

• Collection of product

data

• Data cleansing

• Data formatting (i.e.

IDMP compliant)

127 data elements required

59 new elements

2020 2021

Establish data ownership and governance

Discussion of Questionnaire Results


Planned Roadmap vs Reality


Proposed Roadmap vs Reality


Proposed:

Today

Is this enough?

Use Cases


TOM – Covid-19 new drugs

There are currently no authorised vaccines or treatments in the EU to prevent or

treat COVID-19. However, there are ongoing clinical trials evaluating new potential

treatments.

With TOM implementation

• Faster submission and

communications thanks to

electronic notification (via

SPOR)

• Linked system accelerates

procedural efficiency

• Telematics allows data

exchange internationally

Potential faster approvals!

There is need for a faster approval process and international coordination in

case of extraordinary events like a pandemic

RIMMAH EMA-PMS NCAs

https://www.ema.europa.eu/en/glossary/clinical-trial

TOM – Covid-19 existing drugs: Off label use


Currently different existing medicinal products are tested as off label use for

Covid-19. E.g. Hydroxychloroquine

In the TOM era

PMS-TOM as database and

processes to collect and exchange

structured data on medicinal

products

EMA-PMS NCAs

There is need for structured and quick exchange of information on off label

use of drugs already on the market

Information on off label use of

existing medicinal products will be

retrieved faster in case of

extraordinary events like the Covid-

19 pandemic

TOM – Covid-19 existing drugs: availability


There is a need to prevent and act fast on drug shortages

EMVO

NCA3Regional

database

NCA3Regional

database

NCA3Regional

database

EMASPOR

RIM ERP

IDMP and TOM

implementation will

help in connecting

silos and the

international

networks

Fast response in

case of drug

shortages!

In the TOM era

Currently different countries are experiencing drug shortages due to the Covid-19

pandemic and the effect of lockdowns on manufactures. Moreover, episodes of

shortages on OTC drugs have been registered due to higher demands from the public.

Questions and Discussion


General agreements of the planned milestones


• Start with new initial applications and build upon experience and learnings

Start

Now

• Have a phased wise approach for validation of legacy data

Legacy Data

Agenda · 2020-05-04 · Agenda • Introduction to TOM • Impact of TOM • Current milestones...

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