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1.2.3 Pharmaceutical Industry: Global Regulatory & Harmonization

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Pharmaceutical and Medical Device Innovations

Миннесотский университет

4.4 (оценок: 243) | Зарегистрировано учащихся: 12K

Курс 1 из 5 — Медицинский рынок Специализация

This course in the Healthcare Marketplace specialization gives the learner an in-depth view of the intellectual property creation that is vital to creating breakthrough technologies. Included is an understanding of the strategy deployed for pricing drugs and new technologies as well as the market sizing exercise to identify where future research and development investments should be made.

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4.4 (оценок: 243)

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AN

Mar 17, 2019

Amazing course. Helped me in gaining a better understanding of the various processes involved in the development of a drug and medical device.

HS

Nov 05, 2017

The teaching quality and the instructor's approach to teaching course concepts.&Coursera's platform and ease of use.are so wonderful system

Из урока

The Pharmaceutical Industry: Bench Science to Bedside

In this module you will learn how medical technology goes from ideas to treatments. First we will focus on the pharmaceutical industry. The take-away messages from this module are that there are many exciting ideas that never make it out of the lab. Furthermore, those ideas that do make it out requires hundreds of millions of dollars per innovation. The skills gained from this module to enable a successful capstone is an appreciation of how technologies are innovated a midst a sea of regulation and intellectual property constraints. You will be better prepared to under the features of likely successful drug before it goes to market and competes to enhance and save lives.

1.2.1 Pharmaceutical Industry: Food & Drug Administration3:31

1.2.2 Pharmaceutical Industry: Investigational New Drug / Phase 1 to Phase 44:27

1.2.3 Pharmaceutical Industry: Global Regulatory & Harmonization6:39

Преподаватели

Bryana Mayer
Lecturer
Stephen T Parente
Professor

Текст видео

This is lesson 1.2.3.

We're going to focus on Global Regulatory & Harmonization of the Pharmaceutical Industry.

So, to keep this in perspective,

understand that more than 70 percent of the world's population

are from either Asia Pacific and Emerging Markets, otherwise known APEM.

What we mean by that, is to specifically we're talking about Asia Pacific region,

we're including in that range of countries, India,

the Philippines, South Korea, Taiwan,

obviously China, Hong Kong,

Macau, all fall in that space as well.

For different emerging regions,

we get to Argentina,

Brazil, Chile and Mexico.

For the Middle East and North Africa,

we get to Egypt, Pakistan,

Saudi Arabia, and Turkey.

Sub-Saharan Africa, including South Africa.

Then in Eastern Europe, Russia.

So, when we think about different models for drug regulatory assessment,

there's really two different licensing models that countries can fall in to.

The model of licensing system based upon submission of evidence,

registration and reference countries,

which can include the United States and other places in Europe.

Or the model of licensing system based upon a full assessment of

new drug applications including biological products,

is going to be much more intense.

One thing that is trying to make this work better is to

focus on what's known as a Global Harmonization Initiative,

to really get to a point where the regulatory regimes

that are introduced for new pharmaceutical agents can be much better standardized,

so it's not quite so pluralistic or a hodgepodge.

So, it is a very pretty picture,

the human body is a little more common than necessarily all the colors of the flag.

So, when we think about this idea of an International Conference of Harmonization,

that's IHC, what's the definition and background.

Several things to keep in mind as a joint regulatory project,

the leaders of this are the EU,

Japan, and the United States.

The goal is to improve through harmonization, efficiency of development,

registration of new medicinal products as much as possible bases on scientific consensus,

and look for a commitment by regulatory parties to

implement the harmonization recommendations.

There are six official parties that are co-sponsors directly involved in this.

So, from the sense of authority and research-based industry,

we have the EU, Japan and the USA.

Each of them having their different regulatory components involved.

So, for example, the USA we talked about before,

the EFTA, as well as the Pharmaceutical Research Manufacturers Association.

Same idea comes into play here,

we have both industry as well as regulatory agencies represented.

The official observers for this activity, for harmonization,

is the World Health Organization as well as the European Free Trade Area,

the EFTA, and from Canada,

the Health Protection Branch.

There's a Common Technical Document or

CTD that has been developed for this harmonization idea.

The idea is to find things that are

acceptable for regulatory authorities within the three regions.

Also, this may not define the entire content but

it gives some ideas about where the harmonization will be most effective.

The objectives here are for industry to reduce

the time and resources needed to compile applications,

have an ease of preparation for electronic submissions.

For regulatory authorities, facilitate reviews in a more timely basis,

improved communication with the applicant and simplify

exchange of information between the different Regulators.

Do your acronyms are failing the Common Technical Document?

When we look about what the different organizational modules that we're talking about,

the idea is that with the CTD and again,

this module's three, four, five,

and two, all of these would be

essentially part of that CTD underlying it all be raw data.

So, for example, the Nonclinical review,

Clinical review, written summary is in Module two.

Quality data reports here in Module four, nonclinical data.

Then, Module five, clinical data, study reports.

As far as the Regional Administrative Information

and how this might be applied, that's not part of it,

that gets essentially customized for the country that is going to be applied.

So, we think about this harmonization now, and in the future,

there are new areas that need to be focused on as well besides

just the initial phases to get say the difference of phase one,

phase two, phase three and how they might relate using an FDA regimen to other countries.

There's obviously post marketing programs under some ideas of pharmacovigilance,

particularly opiates issues that come up as well.

Pharmacogenomics, biomarkers and gene therapy, all major issues.

Then, a continued effort between harmonization and

prevention of new interregional disharmony.

Basically, avoiding unilateral development of

requirements in specific areas and try to keep things as consistent as possible.

In terms of continuing this work with globalizing this idea of the harmonization,

there's a Global Cooperation Group.

So, that has a wider array beyond just the three major regions.

So, we have the Asia Pacific Economic Cooperation area,

we have the Gulf Cooperation Council,

we have the Emirates,

in Saudi Arabia and other places to buy counter involved.

Then, a Pan American Network for Drug Regulatory Harmonization generally South American,

that space, and then Africa as well.

So, the idea is to have essentially,

there be an evolution so that this process can go forward

and make it more of a standard across the entire global pharmaceutical market.

There's also Regulators Forum that was started in

2008 including representatives from Australia,

Brazil, China, Taiwan, India,

Russia, Singapore, South Korea;

many which are not part of that harmonization initiatives already.

Their, again, their focuses are very similar and the hope

is that these things can come together to create a truly cooperative group.

This concludes this module on looking at

the harmonization of regulatory regimes for the pharmaceutical market.

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