- e-Learning -
Webcode 25122497
Lidia Cánovas
ASPHALION S.L., Barcelona, Spain
General Manager, Regulatory Affairs Director; Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical industry. She received her degree in Pharmacy from the University of Barcelona, and has a Master in Business Administration in the Pharmaceutical Industry. She is currently the General Manager - Regulatory Affairs of Asphalion, S.L., a consulting company specialized in drug development and regulatory affairs; which she joined in 2003. With over 80 employees with backgrounds in all areas of life science, Asphalion's consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards.Her main activities focuses on consulting and strategic management of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in Scientific Advice, Pediatric Plans, Orphan Drug Designations, Development Plans, Centralized Procedures, Decentralized and Mutual Recognition in permanent contact with the regulatory authorities. She has extensive regulatory and development experience in innovative, biological, biotech, biosimilars and advanced therapy products.
anytime
anytime
online
online
Event - 390 € plus tax
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Our general terms and conditions (dated 1 Juni 2024) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.
SPECIAL OFFERS
CMC Management in Regulatory Affairs
22-23/05/2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.940,00 €
Event - 390 € plus tax
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Our general terms and conditions (dated 1 Juni 2024) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.
SPECIAL OFFERS
CMC Management in Regulatory Affairs
22-23/05/2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.940,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
Module 3 is an essential part of the CTD. It presents data on the quality of the drug substance and drug product. But what data is required? How should Module 3 be structured? These are the topics of our e-learning programme.
In this e-Learning you will:
The e-learning format allows you to create your own schedule, pause and rewind the video at any time, and avoid being pressed for time. You will benefit from the long-term experience of the expert Lidia Cánovas and gain a good overview on the important aspects that concern the structure and content of CTD Module 3. Feel free to pose questions while completing each single or after having completed all four videos.
Here you can get a brief insight into the e-Learning CTD Module 3.
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.
The 'CTD Module 3' e-learning programme comprises four didactic modules that include videos in which expert Lidia Cánovas shares her expertise with you (videos with a time duration between 10 minutes and 45 minutes; for more details see the timetable). You can also download and print the corresponding presentation documents. Each module also includes additional documents (links, guideline texts, etc.). The e-learning ends with an online test, which helps you practise and apply your newly gained knowledge. Once you have completed the four modules and passed the test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months.
Modules
Hours of learning content
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Details
