2022-09-05 2022-09-05 Novotel Frankfurt City +49 69 79303-0 +49 69 79303-930 Novotel Frankfurt City Lise-Meitner-Str. 2, 60486 Frankfurt Frankfurt, 60486 1.190,- € plus tax Linda Bowen https://www.forum-institut.com/seminarDetail/18/referenten/22/22_09/22092612-course-improve-your-regulatory-intelligence-ri-skills_bowen-linda.jpg Improve your Regulatory Intelligence (RI) Skills

After having attended this online seminar, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.

Topics
  • Key components of actionable regulatory intelligence
  • Sources that support global regulatory strategy decision-making
  • Using RI to maintain surveillance on the dynamic regulatory environment
  • Identifying and acting on regulatory trends
  • Ensuring organisations manage regulatory knowledge
Aims and objectives
This seminar focuses on the impact of regulatory intelligence (RI) on regulatory strategies.

Two seasoned regulatory intelligence professionals will address the opportunities that RI provides to organisations, as well as which intelligence skills and competencies regulatory professionals can develop in this role.

We aim at providing you with in-depth knowledge and case studies where RI can contribute to successful regulatory and development outcomes.
Who should attend

This seminar addresses the needs of regulatory affairs professionals directly or indirectly involved in product development and lifecycle management in the BioPharma Industry.

It will be beneficial to those interested in better understanding how to utilise regulatory intelligence (RI) to support regulatory decision-making in global regulatory strategies.

Course Improve your Regulatory Intelligence (RI) Skills

Improve your Regulatory
Intelligence (RI) Skills

RI and its strategic value in
pharmaceutical R&D

Benefits
  • Two outstanding industry experts
  • Limited number of attendees
  • Live in Frankfurt/Germany
  • We are following the IMI quality criteria

Webcode 22092612

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

05.09.2022

05.09.2022

Period

09:00 - 17:00 workshop(from 08:30 re...

09:00 - 17:00 workshop
(from 08:30 registration)
Venue

Frankfurt

Frankfurt

Fee
Your contact person

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

After having attended this online seminar, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.

Topics
  • Key components of actionable regulatory intelligence
  • Sources that support global regulatory strategy decision-making
  • Using RI to maintain surveillance on the dynamic regulatory environment
  • Identifying and acting on regulatory trends
  • Ensuring organisations manage regulatory knowledge
Aims and objectives

This seminar focuses on the impact of regulatory intelligence (RI) on regulatory strategies.

Two seasoned regulatory intelligence professionals will address the opportunities that RI provides to organisations, as well as which intelligence skills and competencies regulatory professionals can develop in this role.

We aim at providing you with in-depth knowledge and case studies where RI can contribute to successful regulatory and development outcomes.

Who should attend

This seminar addresses the needs of regulatory affairs professionals directly or indirectly involved in product development and lifecycle management in the BioPharma Industry.

It will be beneficial to those interested in better understanding how to utilise regulatory intelligence (RI) to support regulatory decision-making in global regulatory strategies.

Detailed programme

09:00 - 17:00 workshop
(from 08:30 registration)

Introduction to regulatory intelligence (RI)
  • Defining RI and its key components; skills and competencies
  • Where the need for RI in pharmaceutical industry stems from

Monitoring the regulatory environment
  • Main sources for regulatory information in key jurisdictions
  • Public information from regulatory authority webpages
  • Identifying regulatory trends

Coffee break


Understanding and shaping the regulatory environment
  • The role of impact analysis in RI
  • Regulatory guidelines and consultation procedures
  • Opportunities and forums for engagement with stakeholders

Lunch


Locating and analysing regulatory precedent
  • Locating and analysing precedent from EU and US drug and biologic sources
  • Assessing the impact of precedent for regulatory decision-making
  • Understanding the importance and context of precedent in regulatory strategy

Communication and knowledge management in RI
  • How to effectively communicate RI within the organisation
  • Tools and processes for communication; Knowledge sharing and management

Coffee break


The strategic value of RI and its evolution
  • Increasingly strategic value progressing R&D towards HTA and access
  • RI role in support of due diligence activities
  • Artificial Intelligence and the next frontiers of RI

End of the seminar


Your benefit

Why you should attend

After having attended this online seminar, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.

You will also be able to understand the strategic importance of RI in regulatory strategies and how organisations can develop skills and competencies in support of their business.

This distinguishes our events

Overall impression: 100 % of the participants' feedback was very good or good (July 2019)

Course content: 100 % of the participants' feedback was very good or good (July 2019)

Recommendations

CMC requirements in Latin America

CMC requirements in Latin America with focus Brazil, Mexico, Colombia, Argentina, Chile and Peru - Register now and part...

21. - 22.09.2022, Online
Details

Marketing Authorisation in Latin America

An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chi...

19. - 20.09.2022, Online
Details

Scientific Writing and Reviewing in Regulatory Affairs

After completing this online seminar, participants will be aware of the key regulatory requirements when preparing texts...

01. - 02.09.2022 in Frankfurt
Details

Expanded Access Programmes

Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expande...

22.09.2022, Online
Details

eSubmission Management in Europe

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity f...

30. - 31.08.2022, Online
Details

Go forward

Pharma FORUM Webcast International

International experts will inform you of the latest trends in global marketing authorisation and drug safety.

Details
Pharma Webcast Global RA & PV
List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
Abbreviations, Glossary
Quality guaranteed!

Your feedback produced as result of 1.8 in 2021. Thank you!

Details
More on our quality criteria

Testimonials

This was well received by the participants in July 2019
Practical information

Dr. Kris Pelzer

InfectoPharm Arzneimittel und Consilium GmbH


Very interactive, only to laok more on the time (sometimes we had to run through the slides)


Interactive session, connected to others up to date information


The communication and the speaker's presentation