2024-12-26 2024-12-26 , online online, 1,690 € plus tax Gloria Frias https://forum-institut.com/seminar/25042452-webcast-series-global-regulatory-requirements-for-drug-device-combination-products-ddcs/referenten/25/25_04/25042452-pharma-course-global-regulatory-requirements-for-ddc-products_frias-gloria.jpg Webcast series: Global regulatory requirements for drug device combination products (DDCs)

Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, MENA, Mexico and other LATAM countries, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.

Topics
  • Concept: Five weekly live webcasts à 3/2 hours with longtime experienced speakers
  • Regions covered: EU, US, China, MENA, Mexico and other LATAM countries
  • Your benefits: Possibility to directly interact with the speaker; you will receive a certificate after each session; you are unable to attend one of the sessions? Profit from the recording of each webcast!


Who should attend
This new webcast series addresses the needs of professionals working in regulatory affairs in the field of drug device development that desire an overview on the currrent developments in the EU, in the US, in China, in MENA countries, in Mexico and other LATAM countries.
Aims and objectives
You are keen to know how to speed up the approval process for your drug device combination products (DDCs) in EU and non-EU countries?

During this new webcast series you will learn about the specific regulatory aspects for product development and lifecycle management of DDCs in the EU, the US, China, MENA, Mexico and other LATAM countries.

Four (local) experts will share valuable information regarding
- types of combination products/definitions;
- legislative framework;
- quality requirements/documentation;
- post-approval activities;
- submission process;
- how to receive approval faster
with you.

After the training course you will have gained a better understanding of the additional and differing regulatory requirements and procedures in the different regions.
You will be provided with tips and tricks to help you master the daily challenges of (post-)approval activities more efficiently.
Your benefit

  • Meet four (local) experts that will share in-depth knowledge with you!
  • Obtain practical RA/CMC know-how for emerging markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Webcast series: Global regulatory requirements for DDC products

Webcast series:
Global regulatory requirements for DDC products

- Online training -

Benefits
  • Tips on how to receive approval for your DDCs faster
  • 5 live webcasts à 2/3h: convenient to integrate into your work routine
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25042452

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

29/04/-27/08/2025

29/04/-27/08/2025

Period

29 April - 6 May - 13 May - 20 May - 27 May
2 or 3 hour live webcast, starts at 9:00 am or 3:30 pm CET
You may dial in 30 minutes before the training starts

29 April - 6 May - 13 May - 20 May - 27 May
2 or 3 hour live webcast, starts at 9:00 am or 3:30 pm CET
You may dial in 30 minutes before the training starts
Venue

online

online

Fee
Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, MENA, Mexico and other LATAM countries, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.

Topics

  • Concept: Five weekly live webcasts à 3/2 hours with longtime experienced speakers
  • Regions covered: EU, US, China, MENA, Mexico and other LATAM countries
  • Your benefits: Possibility to directly interact with the speaker; you will receive a certificate after each session; you are unable to attend one of the sessions? Profit from the recording of each webcast!


Who should attend
This new webcast series addresses the needs of professionals working in regulatory affairs in the field of drug device development that desire an overview on the currrent developments in the EU, in the US, in China, in MENA countries, in Mexico and other LATAM countries.

Aims and objectives

You are keen to know how to speed up the approval process for your drug device combination products (DDCs) in EU and non-EU countries?

During this new webcast series you will learn about the specific regulatory aspects for product development and lifecycle management of DDCs in the EU, the US, China, MENA, Mexico and other LATAM countries.

Four (local) experts will share valuable information regarding
- types of combination products/definitions;
- legislative framework;
- quality requirements/documentation;
- post-approval activities;
- submission process;
- how to receive approval faster
with you.

After the training course you will have gained a better understanding of the additional and differing regulatory requirements and procedures in the different regions.
You will be provided with tips and tricks to help you master the daily challenges of (post-)approval activities more efficiently.

Your benefit

  • Meet four (local) experts that will share in-depth knowledge with you!
  • Obtain practical RA/CMC know-how for emerging markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Detailed programme

29 April - 6 May - 13 May - 20 May - 27 May
2 or 3 hour live webcast, starts at 9:00 am or 3:30 pm CET
You may dial in 30 minutes before the training starts

Dr Francisco Rodríguez Gómez

9 April 2025, 9:00 am - 12:00 am CET: Regulatory aspects for DDCs for product development and lifecycle management in the EU
  • Types of combination products, definitions
  • EU legislative framework for DDCs
  • Quality requirements/documentation
  • Notified body procedure
  • Post-approval activities
  • How to plan you submission?

Dr Francisco Rodríguez Gómez

6 May 2025, 9:00 am - 11:00 am CET: Regulatory aspects for DDCs for product development and lifecycle management in the US
  • Types of combination products, definitions
  • US legislative framework for DDCs
  • Quality requirements/documentation
  • Post-approval activities
  • Brief overview of submission process

Jack Wong

13 May 2025, 9:00 am - 11:00 am CET: Regulatory aspects for DDCs for product development and lifecycle management in China
  • Types of combination products, definitions
  • Legislative framework for DDCs in China
  • Quality requirements/documentation
  • Post-approval activities
  • Brief overview of submission process
  • How to speed up the approval process? - Tips & tricks

Ala'a Saleem

20 May 2025, 9:00 am - 11:00 am CET: Regulatory aspects for DDCs for product development and lifecycle management in MENA countries
  • Types of combination products, definitions
  • Legislative framework for DDCs in MENA countries
  • Quality requirements/documentation
  • Post-approval activities
  • Brief overview of submission process

Gloria Frias

27 May 2025, 3:30 pm - 5:30 pm CET: Regulatory aspects for DDCs for product development and lifecycle management in Mexico and other LATAM countries
  • Types of combination products, definitions
  • Legislative framework for DDCs in Mexico and other LATAM countries
  • Quality requirements/documentation
  • Post-approval activities
  • Brief overview on submission process

Our partner

ASPHALION

Asphalion is an international Scientific and RA consultancy company. Founded in 2000, Asphalion offers comprehensive services for Drug Development and RA to Pharma, Biotech and Medical Devices companies. The services range from early development, throughout the registration, until marketing and post-commercialization phases of a product.





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