2021-12-27 2022-06-28 , online online, 1.790,- € plus tax Ala'a Saleem https://www.forum-institut.com/seminarDetail/102/referenten/22/22_06/22062051-online-course-pv-requirements-in-emerging-markets_saleem-alaa.jpg Pharmacovigilance Requirements in China - LATAM - Russia - MENA

The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.

Topics
  • Legal framework in selected (emerging) countries
  • Similarities and differences compared to EMA regarding ADR collection and reporting
  • PSMF, PSURs and RMPs - country-specific requirements
  • How to integrate local PV systems into a global system
  • Cooperating successfully with the markets in China, LATAM, Russia and MENA
Aims and objectives
Regulatory expectations around risk management for medicinal products in emerging markets are competing with the stringent standards set by the EU/ICH regions. The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix.

Our experts will give you a detailed update on the current legal and regulatory background and on your duties with regard to:
  • ADR collection and reporting
  • PSUR requirements
  • Risk management plans (RMPs)
  • PSMF in selected countries

In addittion, our online-seminar will help you to create a structure to integrate your local PV system into a global system.
Who should attend

This seminar addresses the needs of people who work in the pharmaceutical industry. It will particularly benefit those dealing with international pharmacovigilance issues, such as

  • drug safety managers,
  • clinical trials managers and
  • regulatory affairs managers.

Good knowledge of the European pharmacovigilance framework is participation prerequisite.

Course PV requirements in emerging markets

Pharmacovigilance Requirements in China - LATAM - Russia - MENA

China - LATAM - Russia - MENA

Benefits
  • Interactive online format
  • Experts with local know-how
  • Firsthand information
  • We are following the IMI quality criteria

Webcode 22062051

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

27. - 28.06.2022

27. - 28.06.2022

Period

Day 1: 9:00 a.m. - 5:00 p.m.Day 2: 9...

Day 1: 9:00 a.m. - 5:00 p.m.
Day 2: 9:00 a.m. - 5:00 p.m.
You may dial in 30 min. before the session
The times for breaks at online-seminars are scheduled individually.
Venue

online

online

Fee
Your contact person

Petra Birkenbihl
Conference Manager

+49 6221 500-696
p.birkenbihl@forum-institut.de

Details

The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.

Topics
  • Legal framework in selected (emerging) countries
  • Similarities and differences compared to EMA regarding ADR collection and reporting
  • PSMF, PSURs and RMPs - country-specific requirements
  • How to integrate local PV systems into a global system
  • Cooperating successfully with the markets in China, LATAM, Russia and MENA
Aims and objectives

Regulatory expectations around risk management for medicinal products in emerging markets are competing with the stringent standards set by the EU/ICH regions. The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix.

Our experts will give you a detailed update on the current legal and regulatory background and on your duties with regard to:

  • ADR collection and reporting
  • PSUR requirements
  • Risk management plans (RMPs)
  • PSMF in selected countries

In addittion, our online-seminar will help you to create a structure to integrate your local PV system into a global system.

Who should attend

This seminar addresses the needs of people who work in the pharmaceutical industry. It will particularly benefit those dealing with international pharmacovigilance issues, such as

  • drug safety managers,
  • clinical trials managers and
  • regulatory affairs managers.

Good knowledge of the European pharmacovigilance framework is participation prerequisite.

Detailed programme

Day 1: 9:00 a.m. - 5:00 p.m.
Day 2: 9:00 a.m. - 5:00 p.m.
You may dial in 30 min. before the session
The times for breaks at online-seminars are scheduled individually.

09:00

Introduction and technical warm-up

09:15

Alessandra Zago

PV requirements in China
  • Legal background
  • Similarities to, and differences from, EMA
  • Role of affiliates, external consultants and agents
  • Practical examples and future trends

11:00 Coffee break


11:15

Karin van der Auwera

Intercultural know-how for the emerging markets
  • Save your deadlines: Managing mañana mentalities skilfully
  • Team workers meet top-down hierarchies: navigating around the danger zones

12:30 Lunch break


13:45

Karin van der Auwera

Cooperating successfully with the emerging markets
  • Improving the efficiency of your meetings & virtual conferences
  • Tools & techniques to make your agreements more binding

15:15 Coffee break


15:30

Ala'a Saleem

PV requirements in MENA
  • Legal background
  • Similarities to, and differences from, EMA
  • Role of affiliates, external consultants and agents
  • Practical examples and future trends

16:30

Exchange on experiences with emerging markets

17:00 Day one ends


09:00

Anna Kramar

PV requirements in Russia and EAEU
  • What is EAEU
  • EAEU GVP System
  • National authorities and legislation
  • EAEU GVP updates 2022
  • EAEU GVP aspects vs. national specifics
  • Practical advises for GVP implementation

11:15 Coffee break


11:30

Dr Tanja Peters

Think global, act local
  • How to maintain oversight - Regional PV information sourcing & intelligence
  • Impact of new PV requirements
  • How to integrate local PV systems into a global system
  • Vendor management

13:15 Lunch break


14:30

Raphael Pareschi

Pharmacovigilance requirements in Latin America (in the context of selected countries)
  • Legal background and national authorities
  • Role of affiliates, external consultants and agents

15:30 Coffee break


15:45

Raphael Pareschi

Pharmacovigilance requirements in Latin America (in the context of selected countries) - continued
  • Similarities to, and differences from, EMA with regard to:
    • ADR reporting timelines
    • Patient safety in clinical trials
    • PSUR requirements
    • RMPs
    • PSMFs
    • PV inspections and sanctions
  • Future trends

16:45

Questions and discussion

17:00 Seminar ends


Workshops

Seit 2000 bieten wir Expertenwissen zu verschiedenen Rechtsthemen in englischer und deutscher Sprache an. Zu unseren Kernkompetenzen gehören u.a. das Stoff- und Chemikalienrecht sowie das Pharmarecht.

Information

Send us your questions

Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.
Please send your questions via e-mail to s.wittemann@forum-institut.de

Booking Option

You are interested in attending only one seminar day? Please do not hesitate to contact us.

This distinguishes our events

Overall impression: 100% of the participants’ feedback was very good or good. (June 2019)

Practical benefit:: 100% of the participants’ feedback was very good or good. (June 2019)

Recommendations

Toxicology Summer School

During this summer school you will build a solid toxicological know-how basis and will be informed about the inclusion o...

04. - 06.07.2022, 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

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

Pharmacovigilance Inspection Readiness

Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn...

24.10.2022, Online
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

Go forward

Technical requirements

Here you can find the technical requirements for our online events that must be met.

Details
Technical requirements
Testimonials

Hear from our past delegates and sponsors and learn more about the events.

Details
Testimonials
Quality guaranteed!

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

Details
More on our quality criteria

Testimonials

Comment of former participants (June 2020)
My expectations were to get a refresher + information on recent developments in PV-requirements for all anounced markets; my expectations were fully met. Positive was the opportunity of immediate and direct interactions though we met only virtually.


Very useful and informative for people operating in emerging markets.


Very detailed information, well structured, fruitful discussions


Very helpful for our daily work and with view to new challenegs in emerging markets. I would like to introduce new ideas in my PV Team.

This is why the course in June 2019 met the participants' expectations:
New and good information on cultural differences and PV-requirements in the different countries. Methods to get an overview about the different PV-requirements (e.g. timelines for PSURs etc.).


Good overview of the newest regulations and reporting guidelines.