2024-03-01 2024-03-01 , online online, 1,590 € plus tax Yingxia Zhang https://www.forum-institut.com/seminar/24062050-pharmacovigilance-requirements-in-china-latam-eaeu-mena/referenten/24/24_06/24062050-online-course-pv-requirements-in-emerging-markets_zhang-yingxia.jpg Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in 5 consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!

Topics
  • Legal framework in selected (emerging) countries or regions
  • Similarities and differences in ADR collection and reporting compared to EMA standards
  • Country-specific requirements for PSMF, PSURs and RMPs
  • How to integrate local PV systems into a global system
  • Special focus on China, LATAM, EAEU and MENA


Who should attend
This seminar caters to individuals in the pharmaceutical industry, particularly those dealing with international pharmacovigilance issues, such as:
  • Qualified Persons for Pharmacovigilance (QPPVs)
  • drug safety managers
  • clinical trials managers
  • regulatory affairs managers

Good knowledge of the European pharmacovigilance framework is prerequisite for participation.
Aims and objectives
International pharmaceutical manufacturers, depending on the region, face different regulatory requirements. In the field of pharmacovigilance, risk management for pharmaceuticals in emerging markets often competes with the stringent standards set in the EU/ICH regions. The diverse and relevant regulations of individual countries or regions require a finely tuned balance, ensuring that all local pharmacovigilance systems used by a company are integrated into a unified and truly global pharmacovigilance matrix.

Our experts provide you with a comprehensive update on the current legal and regulatory landscape, with a focus on your responsibilities related to the following:
  • Collection and reporting of adverse drug reactions (ADR)
  • Periodic Safety Update Reports (PSUR) requirements
  • Requirements for Risk Management Plans (RMPs)
  • Global and local Pharmacovigilance System Master Files (PSMFs)
Your benefit

This series of five webcasts deepens your understanding of the requirements and conditions in China, LATAM, the EAEU and MENA. In addition to the regulatory aspects, you will also become acquainted with intercultural considerations, providing you with a global overview of your pharmacovigilance system.

After the webcast series, you will be better equipped to comprehend local pharmacovigilance systems in emerging countries and regions. Furthermore, you will know how to integrate them into your global PV system and maintain an overview.

Course PV requirements in emerging markets

Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

Webcast series covering legal framework, country-specific requirements and more

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

Webcode 24062050

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

10-11/06/2024

10-11/06/2024

Period

Day one: Webcasts 1-3: 09:00-11:00, 12:00-14:30 and 15:00-17:00 CEST
Day two: Webcasts 4+5: 12:0-14:00 and 15:00-17:00 CEST

Day one: Webcasts 1-3: 09:00-11:00, 12:00-14:30 and 15:00-17:00 CEST
Day two: Webcasts 4+5: 12:0-14:00 and 15:00-17:00 CEST
Venue

online

online

Fee
Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in 5 consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!

Topics

  • Legal framework in selected (emerging) countries or regions
  • Similarities and differences in ADR collection and reporting compared to EMA standards
  • Country-specific requirements for PSMF, PSURs and RMPs
  • How to integrate local PV systems into a global system
  • Special focus on China, LATAM, EAEU and MENA


Who should attend
This seminar caters to individuals in the pharmaceutical industry, particularly those dealing with international pharmacovigilance issues, such as:
  • Qualified Persons for Pharmacovigilance (QPPVs)
  • drug safety managers
  • clinical trials managers
  • regulatory affairs managers

Good knowledge of the European pharmacovigilance framework is prerequisite for participation.

Aims and objectives

International pharmaceutical manufacturers, depending on the region, face different regulatory requirements. In the field of pharmacovigilance, risk management for pharmaceuticals in emerging markets often competes with the stringent standards set in the EU/ICH regions. The diverse and relevant regulations of individual countries or regions require a finely tuned balance, ensuring that all local pharmacovigilance systems used by a company are integrated into a unified and truly global pharmacovigilance matrix.

Our experts provide you with a comprehensive update on the current legal and regulatory landscape, with a focus on your responsibilities related to the following:

  • Collection and reporting of adverse drug reactions (ADR)
  • Periodic Safety Update Reports (PSUR) requirements
  • Requirements for Risk Management Plans (RMPs)
  • Global and local Pharmacovigilance System Master Files (PSMFs)

Your benefit

This series of five webcasts deepens your understanding of the requirements and conditions in China, LATAM, the EAEU and MENA. In addition to the regulatory aspects, you will also become acquainted with intercultural considerations, providing you with a global overview of your pharmacovigilance system.

After the webcast series, you will be better equipped to comprehend local pharmacovigilance systems in emerging countries and regions. Furthermore, you will know how to integrate them into your global PV system and maintain an overview.

Detailed programme

Day one: Webcasts 1-3: 09:00-11:00, 12:00-14:30 and 15:00-17:00 CEST
Day two: Webcasts 4+5: 12:0-14:00 and 15:00-17:00 CEST

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
  • GVP System in EAEU
  • Legislation and authorities
  • EAEU GVP update 2022

17:00 Day 1 ends


12:00 Day 2 begins


12:00 - 14:00

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

14:00 - 15:00 Working break


15:00 - 17:00

Diana Gonzalez, Diego A. Salas

Webcast 5: 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 Webcast series ends


Further information

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green 'Participate' button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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