Dr Francisco Rodríguez Gómez
ASPHALION S.L., Barcelona, SPAIN
Scientific and Regulatory Affairs | Medical Technology | In vitro Diagnostic Medical Devices | Combination Products Francisco Rodríguez Gómez 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. His commitment to furthering his understanding led him to a PhD in Biomedicine, with a focus on Regulatory Science, and to a Postgraduate Degree to deepen his insights into Medical Device Expertise. His area of expertise includes substance-based medical devices, health products in borderline regulatory categories, software, and drug device combinations. He is co-cordinator of the drug device combination working group of the Spanish Association of Pharmacists in Industry (AEFI).
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 (Lung) Wong
CEO of RNAscence and Founder of Asia Regulatory Professsionals Association (ARPA), SINGAPORE
Jack Wong has over 26 years of experience in the Pharma and MedTech sectors. He is the founder of the Asia Regulatory Professionals Association (ARPA), which has a membership of more than 7,000 professionals. Additionally, he is the author of the Medical Regulatory Affairs Handbook (3rd edition). He holds adjunct professor and lecturer positions at the Chinese University of Hong Kong, Hong Kong University, the National University of Singapore, and Tohoku University in Japan. He is also the CEO of RNAscence, a biotech start-up spin-off from Nanyang Technological University and the National Skin Centre in Singapore.
30/04 - 02/07/2026
30/04 - 02/07/2026
30 April - 7 May - 18 May - 21 May 2026
2 or 3 hour live webcast, starts at 9:00 am CET
You may dial in 30 minutes before the training starts
online
online
Event - 1,450€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 1,450€ plus tax
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, and MENA region, 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, and MENA region.
Three (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.
30.04.2026
Dr Francisco Rodríguez Gómez
07.05.2026
Dr Francisco Rodríguez Gómez
18.05.2026
Jack Wong
21.05.2026
Ala'a Saleem
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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