Introduzione
The regulatory process from product design to market entry on a global scale is a challenging endeavor for medical technology companies. Particularly for small and medium sized medtech businesses it is a challenge to get an overview of the diverging device market authorization paths that differ considerably from the European Union (EU) approval.
This course gives participants an overview how to plan and implement international Medical Device Registration from a European regulatory perspective with a focus on high risk devices including device drug combination medical devices, software medical devices and in-vitro diagnostics. The participants will be given insight on the regulatory and quality system strategy, product registration and local agent requirements in major device markets in the Americas, the Asia Pacific and China.
Delegates will acquire competences in international medical device registration pathways, timelines and costs and learn from hands-on industry practice. The course will cover both initial market access as well as life cycle requirements and quality system implications.
MODULE 1
Regulatory strategy & the Americas
- Introduction: How to control market authorization assets
- Preparation & post approval considerations
- Impact of the Medical Device Single Audit Program – MDSAP
- Canadian Medical Devices Regulations
- Brazil: ANVISA and INMETRO requirements and market access steps
- Overview on registrations pathway in Argentina and Mexico
- Q&A
MODULE 2
China
- National Medical Products Administration (NMPA) responsibilities and structure
- Overview on Laws, Regulations and Guidelines
- Approval steps and timelines according to risk class
- Practical experiences. What I should have done differently
- Q&A
The Asia Pacific
- Taiwan FDA (TFDA) registrations
- Singapore Health Science Authority (HSA) approvals
- Malaysia Medical Device Authority pathway
- Indonesia NA-DFC requirements
- Q&A
This course is addressed to professionals in MedTech companies with an international market perspective: Regulatory Affairs; Clinical Operations, Quality Assurance, Project Managers, Sales and other departments involved in international market access.
Participant experience
No previous experience in international medical devices registration is needed. Experience with medical devices regulatory processes in Europe may be helpful.
The training will consist in lectures, case studies discussion and Q&A sessions.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.
Online Training – 2 modules
20 April 2023 9:30 am – 12:30 pm CEST
21 April 2023 9:30 am – 12:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 660,00* (until 05 April 2023)
Ordinary: € 850,00*
Freelance – Academy – Public Administration**: € 430,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
