2023-01-30 2023-01-30 , online online, 1,890 € plus tax Ala'a Saleem https://www.forum-institut.com/seminar/23062053-pharmacovigilance-requirements-in-china-latam-eaeu-mena/referenten/23/23_06/23062053-online-course-pv-requirements-in-emerging-markets_saleem-alaa.jpg Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

6 consecutive webcasts - Pharmacovigilance in China, LATAM, EAEU, MENA, Latin America and on strategic questions

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
  • Special focus on China, LATAM, EAEU and MENA


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.
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 6 consecutive webcasts.

These webcasts will help you to create a structure to integrate your local PV system into a global system.
Your benefit

These 6 consecutive webcasts will bring you closer to the requirements and conditions in China, LATAM, EAEU and MENA. The event not only highlights the professional topics but also familiarizes you with intercultural aspects and thus offers you a comprehensive overview.

Course PV requirements in emerging markets

Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

China - LATAM - Russia - MENA

Benefits
  • PV practice goes global
  • Experts with local know-how
  • Firsthand information
  • We are following the IMI quality criteria

Webcode 23062053

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

12-13/06/2023

12-13/06/2023

Period

Day one: Webcasts 1-3: 9:00, 12:00 a...

Day one: Webcasts 1-3: 9:00, 12:00 and 15:00 start; 17:00 end of day one
Day two: Webcasts 4-6: 9:00, 12:00 and 15:00 start; 17:00 end of day two
Venue

online

online

Downloads
Fee
Your contact

Dr. Henriette Wolf-Klein
Conference Manager

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

Details

6 consecutive webcasts - Pharmacovigilance in China, LATAM, EAEU, MENA, Latin America and on strategic questions

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
  • Special focus on China, LATAM, EAEU and MENA


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.
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 6 consecutive webcasts.

These webcasts will help you to create a structure to integrate your local PV system into a global system.

Your benefit

These 6 consecutive webcasts will bring you closer to the requirements and conditions in China, LATAM, EAEU and MENA. The event not only highlights the professional topics but also familiarizes you with intercultural aspects and thus offers you a comprehensive overview.

Detailed programme

Day one: Webcasts 1-3: 9:00, 12:00 and 15:00 start; 17:00 end of day one
Day two: Webcasts 4-6: 9:00, 12:00 and 15:00 start; 17:00 end of day two

09:00 Day 1 begins


09:00 - 11:00

Yanjie Shen, Yingxia Zhang

Webcast 1: 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 - 12:00 Working break


12:00 - 14:30

Ala'a Saleem

Webcast 2: PV requirements in MENA
  • Legal background
  • Similarities to, and differences from, EMA
  • Role of affiliates, external consultants and agents
  • Practical examples and future trends

14:30 - 15:00 Working break


15:00 - 17:00

Dr Edelgard Rehak

Webcast 3: PV requirements Eastern Europe (focus on EAEU)
  • EAEU GVP System
  • National authorities and legislation
  • EAEU GVP updates 2022
  • EAEU GVP aspects vs. national specifics
  • Russia as a dominating country in the EAEU?

17:00 Day 1 ends


09:00 Day 2 begins


09:00 - 11:00

Dr Tanja Peters

Webcast 4: 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

11:00 - 12:00 Working break


12:00 - 14:00

Karin van der Auwera

Webcast 5: Intercultural know-how for the emerging markets & Cooperating successfully with the emerging markets
Intercultural know-how for the emerging market
  • Save your deadlines: Managing mañana mentalities skilfully
  • Team workers meet top-down hierarchies: navigating around the danger zones
Cooperating successfully with the emerging markets
  • Improving the efficiency of your meetings & virtual conferences
  • Tools & techniques to make your agreements more bindingInteractive

14:00 - 15:00 Working break


15:00 - 17:00

Diana Gonzalez - invited

Webcast 6: PV requirements in Latin America (in the context of selected countries)
  • Legal background and national authorities
  • Role of affiliates, external consultants and agents
  • Similarities to, and differences from EMA
  • Future trends

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.

This distinguishes our events

Overall score of all evaluations in 2022

Five stars on Trustpilot = Excellent

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Technical requirements

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

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Technical requirements
Quality guaranteed!

Your feedback produced as result of 1.8 in 2022. Thank you!

Details
More on our quality criteria

Testimonials


Good overview of the newest regulations and reporting guidelines.

A highly recommended seminar for every PV employee who works with international PV partners and needs to have deeper knowledge about PV requirements in these regions.


Interesting and innovative in order to understand the new PV requirements.


I really enjoyed the whole training. Really very good, the comparison between regions and the EU.


Very good topic, very interesting and exciting.


Excellent overview of reporting requirements.