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R4A idea 1

Abby Stock-Duerdoth

Created on November 30, 2023

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Transcript

colab

manage

patients

funding

foundational modules

Validation

Screening

Candidate identification

Intro

Introduction

Landscape

applying for funding

TPP to RDP

Need identification

Indirect data

The TPP

as a tool

Direct data

princiapls

preclinical

clinical

approvals & access

post auhtporosation

strategy

agreements & contracting

principals

where & when

existing support

training

Funding for funders

engagement

off label

on label

buisness case

seeking MA

CT regs

SA

strategy and data

activities & pathways

landscape

Strat+data

Explore

Patietn ready

Market ready

strat+data

delivery

path to market

Economic

design

ethics+regs

recruit

Finding

regs

access

clinical

Preclin

TPP

Intro

R4A currciculum

Core m odules

routes

sociotal

1. Stratgey

3. proving impact

2. candidate development

0. General

4. Licencing

5. Market access

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Gap Analysis

Using a TPP?

What is a TPP?

TPP to RDP

Need identification

Indirect data

The TPP

Direct data

Target Product Profile

as a tool

agreements & contracting

principals

where & when

existing support

princiapls

preclinical

clinical

approvals & access

post auhtporosation

strategy

training

engagement

Introduction

Landscape

applying for funding

Funding for funders

colab

manage

patients

funding

foundational modules

off label

on label

buisness case

seeking MA

CT regs

SA

strategy and data

activities & pathways

landscape

Strat+data

Explore

Validation

Patietn ready

Market ready

strat+data

delivery

path to market

Economic

design

ethics+regs

recruit

Screening

Candidate identification

Finding

regs

access

clinical

Preclin

TPP

Intro

R4A currciculum

Core m odules

Need identification

TPP to RDP

routes

Indirect data

The TPP

sociotal

Direct data

Intro

1. Stratgey

3. proving impact

2. candidate development

0. General

4. Licencing

5. Market access

The TPP

TPP to RDP

Need identification

Indirect data

The TPP

Direct data

Book chapter

WHO page

Biocurate fact sheet

Learn more here:

A target product profile is a description of the medicine or device you want to make. It outlines the key characteristics the product should have in order to meet the needs of a specific target population.The world health organisation (WHO) says: They describe (1) the preferred and (2) the minimally acceptable profiles for vaccines, therapeutics, diagnostics or medical devices criteria. They also provide information for funders and developers on the performance and operational characteristics expected of products if they are to meet WHO’s needs.

What is a TPP?

Module 2: TPP

Using a TPP

GAP analysis

What is a TPP?

The TPP

TPP to RDP

Need identification

Indirect data

The TPP

Direct data

Walk through and example

Article

Learn more here:

When creating a TPP, it is important to carry out a gap analysis. This process involves asking (and answering) questions about what data you have now and what data you need in order to apply for marketing approval for a drug. The gap is likely to be quite large, so breaking it down into smaller questions can help. What pre clinical work needs to be done? What patient populations are we going to focus on?

Gap analysis

Module 2: TPP

Using a TPP

GAP analysis

What is a TPP?

The TPP

TPP to RDP

Need identification

Indirect data

The TPP

Direct data

Example TPP and webinar

Learn more here:

Once you’ve created a TPP and carried out you Gap analysis, you can pull them together into a research development plan. a) TPP asks ‘what do you want to make’. b) GAP asks ‘what do we need to make that’. c) RDP asks ‘how are we going to do it’.

Using a TPP

Module 2: TPP

Using a TPP

GAP analysis

What is a TPP?

Got an idea?

Let the communication flow!

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.

Got an idea?

Let the communication flow!

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.
  • Usign a TPP
  • Gap Analysis

Click on a topic to get started

The TPP

In this submodule you'll learn about what a TPP is and how to use it
  • What is a TPP?

Got an idea?

Let the communication flow!

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.

Got an idea?

Let the communication flow!

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.