1.2.3 Pharmaceutical Industry: Global Regulatory & Harmonization

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Из курса от партнера University of Minnesota

Pharmaceutical and Medical Device Innovations

177 оценки

University of Minnesota

Pharmaceutical and Medical Device Innovations

177 оценки

Курс 3 из 5 — Specialization Healthcare Marketplace

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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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

Познакомьтесь с преподавателями

Bryana Mayer
Lecturer
Carlson School of Management, Medical Industry Leadership Institute
Stephen T Parente
Professor
Carlson School of Management, Department of Finance

This is lesson 1.2.3, Global Regulation and

Harmonization in the Pharmaceutical Industry.

More than 70% of the world's population is in the Asia Pacific market.

And that's not too surprising when you think of India, and

China, and some of the larger companies in the world, all within that Asian region.

So other international and emerging regions include China, again,

Hong Kong, Latin America, the Middle East, Sub-Saharan Africa, and Eastern Europe.

There are two licensing models for drug regulatory assessment.

Model of licensing system based on submission of evidence of registration in

reference countries, and then a model of licensing system based upon a full

assessment of new drug applications, including biological products.

So this shows the Global Harmonization Initiatives across the world.

Really the goal here is to have enough harmonization that regulatory

standards can apply to most of the countries across the world.

So the International Conference on Harmonization involves regulatory and

industry projects.

It involves big countries in Europe, Japan and the United States, and

it's focused on improving efficiency in the development and

registration of new medicinal products.

It's based on scientific consensus and commitment by

regulatory parties to implement its regulations and recommendations.

ICH involves six official parties, both the regulatory bodies and

the trade organizations within Europe, Japan, and the United States.

There are also some official observers, including the World Health Organization,

the European Free Trade Area, and Canada.

So ICH has a Common Technical Document that harmonizes

the format for registration applications.

It is acceptable by regulatory authorities, but does not define content.

Objectives for the document for industry include reducing time and

resources needed to compile applications and

prepare electronic submissions more easily.

For regulatory authorities, the objective is to facilitate reviews,

improve communication, and

simplify exchange of information between regulators.

So the idea behind the Common Technical Document is really to put

some structure behind this harmonization.

And the Common Technical Document is organized in modules starting with raw

data, moving through clinical and nonclinical data, quality data.

But there's still some information that is handled regionally that is not part of

the Common Technical Document.

So new areas to develop ICH guidelines include post-marketing data,

pharmacogenomics data, biomarker information, and

information on gene therapy.

Continued harmonization involves the prevention of new interregional

disharmony.

So it's really designed to avoid unilateral development of requirements in

specific areas.

So as I mentioned earlier, originally the ICH involved the United States,

the European Union, and Japan.

But the goal really is to go broader, and

involve regional harmonization initiatives across smaller regions.

There's also a Regulators Forum, including representatives from developing and

developed countries with a key focus on clinical trials and pharmacovigilance.

This concludes Module 1.2.3, Harmonization and

Global Regulation Within the Pharmaceutical Industry.

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