From Development to Approval - Strategic Planning in a Changing EU Framework
Webcode 26072604
Dr Ida Caramazza
Senior Expert Regulatory Affairs
Ida Caramazza has a Degree in Pharmaceutical Technology and Chemistry and a Diploma as Specialist in Toxicology . She has been working in the Pharmaceutical field since the '80s. Her experience started with preclinical research activity in Pharmaceutical Companies and then continued in the regulatory affairs sector, working for Regulatory Consultancy Firms and for international Pharmaceutical Companies, being involved in Regulatory Affairs activities mainly on medicinal products, but also on other healthcare products, such as medical devices, food supplements and cosmetics. She currently works as a Senior Regulatory Affairs Consultant on regulatory strategy projects, regulatory activities and regulatory training. She is also involved in teaching activities at the University Master in Regulatory Sciences.
Viktoria Behse
regenold GmbH, Badenweiler, GERMANY
Senior Expert Regulatory Affairs
Dr. Axel Korth
Corporate Counsel - Commercial, Biocon Biologics, London
Dr. Axel Korth is a senior life sciences lawyer with experience both as an in-house legal counsel as well as in private practice. Axel Korth is currently working as Corporate Counsel at Biocon Biologics providing legal and compliance-related advice to Biocon's EU business operations. Prior to joining Biocon Biologics, Axel worked at as Assistant General Counsel at Shionogi and Senior Legal and Regulatory Affairs Advisor at EUCOPE representing the organization at the EC, EMA, HMA, CMDh and other fora with a focus on regulatory and legal affairs. Prior thereto, Axel worked as Head Legal DACH at Biogen with a focus on market access, pricing and reimbursement, general healthcare law and compliance, antitrust and competition, public policy and government affairs. Axel also worked in commercial legal roles as Head Legal MEA and Senior Legal Counsel WEMEA at Sandoz (Novartis group) and held positions of continuing seniority at international law firms Shearman & Sterling LLP and Taylor Wessing.
Melita Lusa (PhD)
MAIN5, Frankfurt, GERMANY
Melita is a Life Sciences Consultant and Project Manager at MAIN5 with over 10 years of experience in the pharmaceutical industry. She specializes in Regulatory Information Management (RIM), digital transformation, and data strategy, with expertise in implementing IDMP and xEVMPD standards.
She supports global clients in RIMS implementation, IDMP data readiness, and IT solution development to streamline compliance and manage regulatory data. Previously, Melita worked at TEVA and Amplexor, gaining experience in GMP, quality assurance, regulatory submissions, master data governance and RIMS.
She holds a PhD in Analytical Chemistry and is passionate about driving regulatory innovation and bridging business, IT, and regulatory functions for successful system implementations.
More information please click here.
09/07/2026
09/07/2026
9:00-17:00 CET - online seminar
You may dial in 30 minutes before the training starts
online
online
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
This intensive seminar provides strategic insights into EU regulatory affairs. With updates on the new EU pharmaceutical legislation, you'll understand the regulatory framework for all important strategic decisions. Learn how to align your regulatory strategy with corporate goals, collaborate successfully with other departments & authorities, and use tools like RIMS effectively.
This intensive seminar offers a comprehensive overview of strategic regulatory planning. From foundational principles to hands-on tools, all key aspects of regulatory strategy will be addressed - including authority coordination, project planning, and structured data use.
You will learn how to position regulatory affairs as a core strategic function within your organisation and how to enhance its impact through cross-functional collaboration and digital solutions. You will also explore how the revised EU pharmaceutical framework will impact your regulatory strategy and how to use regulatory information management systems (RIMS) for strategic data use.
At the end of the training, you will be equipped with essential methods and insights to develop and implement your own successful regulatory strategy.
09:00 Welcome & Technical Warm-Up
09:15
Dr Ida Caramazza
09:45
Dr Ida Caramazza
10:45 Coffee Break
11:00
Viktoria Behse
11:30
Viktoria Behse
13:00 Lunch break
14:00
Dr Axel Korth
15:15 Coffee Break
15:30
Dr Melita Lusa
16:45 Closing Discussion & Feedback Session
17:00 End of Seminar
Do you lack basic marketing authorisation expertise? Then, we would recommend the e-Learning 'Introduction to EU Marketing Authorisation'.
This will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.
Simply register for the seminar clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€290 + local VAT rather than €390 + local VAT).
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.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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