- Online training -
Webcode 25042452
Gloria Frias
Rafconsulting, Mexico City, MEXICO
CEO & Founder
Gloria has a background in Pharmacy and Chemistry. She has worked for 10 years in the pharmaceutical industry, in both local Mexican companies and American and European multinational companies. After that, she started freelancing in regulatory services until she established Rafconsulting 11 years ago, with a solid team to provide regulatory and pharmacovigilance services.
Currently, the team helps national and international companies to successfully launch regulated products in Mexico. They have more than 32 years of experience writing success stories. They have assisted the healthcare industry and other sectors requiring regulatory services with marketing approvals for a broad range of products such as pharmaceuticals, medical devices, food supplements, cosmetics, among others. They are also experts in consulting on borderline products and start-ups, and they provide turnkey services when requested by clients. In some cases, they also coordinate registrations with their agents throughout Latin America.
More information please click here.
Dr Francisco Rodríguez Gómez
ASPHALION S.L., Barcelona, SPAIN
Scientific and Regulatory Affairs | Medical Technology | In vitro Diagnostic Medical Devices | Combi Francisco has developed his knowledge in the field of regulatory science for medical devices through dedicated study and experience. He completed his undergraduate studies in Biomedicine, followed by a Master's degree in the Pharmaceutical and Biotechnology Industry, a MedTech Expert postgraduate degree and an Industrial PhD in Biomedicine with special focus on Regulatory Science. Francisco is active member of the Spanish Association of Pharmacists in the Industry (AEFI), where he is involved in the coordination of the drug device combination products working group. His area of expertise includes substance-based medical devices, health products in borderline regulatory categories, software, and drug device combinations.
Ala'a Saleem
Science Forum (SIPS), Amman, JORDAN
Deputy General Director "Technical Affairs"
15 years’ experience in different fields comprising RA and IPR in the pharmaceutical area. As a member of SIPSMENA team, Ala’a has been subjected to various other areas in the pharmaceutical industry such as agent selection, legal requirements, market access and others.
More information please click here.
Jack Wong
Founder of Asia Regulatory Professsionals Association, Singapore
Jack has more than 26 years experience in the Pharma and MedTech sector. He is the founder of Asia Regulatory Professionals Association (ARPA) with more than 7000 members. He is author of "Medical Regulatory Affairs Handbook" (3rd edition). He has a position as adjunct professor/lecturer at the Chinese University of Hong Kong, Hong Kong University, National University of Singapore and Tohoku University Japan. He is CEO of RNAscence (a Biotech start-up spin off from Nanyang Technological University and National Skin Centre Singapore).
29/04/-27/08/2025
29/04/-27/08/2025
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
online
online
Veranstaltung - 1,690 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,690 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
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.
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.
Dr Francisco Rodríguez Gómez
Dr Francisco Rodríguez Gómez
Jack Wong
Ala'a Saleem
Gloria Frias
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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