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Our Strategy

Developing Regulatory Intelligence & Representing the Human Microbiome Supply Chain

Microbiome Regulatory Expertise

Microbiome Regulatory Expertise – The PRI is Europe’s leading microbiome regulatory science expertise center and was founded in 2010 to support the development of microbiome-based medicines for the EU market, for the benefit of patients.

Future of Medicine

Understanding the microbiome and its role in human health, however, represents a paradigm shift in how medicines will be developed, as innovation and industry often outpace regulation. The PRI was founded to make Microbiome-derived medicines a reality in Europe.

Unique Collaborative Approach

A Unique Collaborative Approach – The PRI applies a unique collaborative approach to improve market access and provide technical and regulatory intelligence for its members – the ‘Share & Learn’ Approach , an atypical solution to a complex challenge.

Partnering Membership

Active Support

Active Support

Active support in identifying potential partnerships

Annual Event

Annual Event

Invitation to annual exclusive Member Event for Partnering + Innovation Showcase

Task Groups

Task Groups

PRI Task Groups* (Non-regulatory topics only) 

Digital Promotion

Digital Promotion

Promotion on PRI website (logo, blog articles, newsletters) & social media (LinkedIn, Twitter)

Discounted Rates

Discounted Rates

Discounted Rate (up to 20%) to attend + advantages for sponsoring at the annual Pharmabiotics Conference & Partnering event

Regulatory Membership

*Includes all advantages of Partnering Membership

On-site Workshops

On-site Workshops

Customized on-site workshops with our regulatory affairs experts to de-risk and accelerate your product development

Unique Expertise

Unique Expertise

PRI internal guidelines & previous scientific advice intelligence

Task Groups

Task Groups

All PRI Task Groups (regulatory & technical). These ad-hoc working groups focus on the most pressing questions facing the industry – eg. ‘Clinical Studies’, ‘Analytics’, ‘Safety’, ‘Inactivated Cells’…

Future Outlook

Future Outlook

Foresight of future regulatory challenges

Regulatory Strategy

Regulatory Strategy

PRI regulatory strategy (EMA Scientific Advice Request dossier results) – the ‘overview effect’

Keeping Up

Keeping Up

Current European regulatory intelligence updates Eg. European Pharmacopeia or CAMD Medical Device Status

Valuable Insight

Valuable Insight

Actively provide you with a unique understanding of the authorities’ mindset/approach to microbiome-based products (LBPs/MMPs)

Fee Structure

Scroll to view our Regulatory Membership Fees Structure

Membership Fees Structure

Regulatory Membership

(Tech Transfer-TTO Projects, Biotechs and Commercial groups)

Incubator & Partnering Membership

(Microbiome Accelerators/ Incubators, Service Providers & Academic groups)

Organization

Organization 

Membership Dues (annual)

Membership Dues (annual)

Tech. Transfer Project

Biotech (not-yet-in-profit)

Commercial (profitable)

€ 4 000

€ 6 000

€ 10 000

Incubator Member

Partnering Member

Associate Member (Research/Academia)

€ 1 500

€ 1 500

€ 0

Membership Fees Structure

Regulatory Membership

(Tech Transfer-TTO Projects, Biotechs and Commercial Groups)

Organization

Membership Dues (annual)

Tech. Transfer Project

Biotech (not-yet-in-profit)

Commercial (profitable)

€ 4 000

€ 6 000

€ 10 000

Partnering Membership

(Microbiome Accelerators/Incubators, Service Providers & Academic groups)

Organization

Membership Dues (annual)

Incubator Member 

Partnering Member 

Associate Member 

€ 1 500

€ 1 500

No Charge