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Medical Devices Registration at an International Level

Regulatory strategy and steps for medical device market access with an eye on the Americas, the Asian pacific Region and China

Date

04 June 2020

Location

Budapest

Language

English

Medical Devices Registration at an International Level

The regulatory process from product design to market entry on a global scale is a complex endeavor for medical device professionals. Particularly for small and medium sized businesses it is a challenge to get an overview of the diverging market authorization pathways that differ considerably from the European Union (EU) approval pathway.

This one-day course gives participants an overview how to plan and implement international Medical Device Registration from a European regulatory perspective. 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 Region and China.

Delegates will acquire key competences in international medical device registrations 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

  • How to control market authorization assets
  • Preparation steps
  • Post approval considerations
  • The impact of MDSAP
  • What I should have done differently

Module 2: The Americas

  • Canada: How to obtain Health Canada device license
  • Brazil: ANVISA and INMETRO requirements
  • Overview on the registration in Argentina and Mexico

Module 3: Asia Pacific

  • Taiwan FDA (TFDA) registrations
  • Singapore Health Science Authority (HSA) approvals
  • Malaysia Medical Device Authority pathway
  • Indonesia NA-DFC requirements

Module 4: China

  • China Food and Drug Administration (CFDA) responsibilities and structure
  • Laws, Regulations and Guidelines
  • Approval steps and timelines for high risk products
  • Practical experiences
Arkan Zwick
Arkan Zwick Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria

Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven 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. He is a lecturer at the University of Applied Sciences in Vienna and speaker on life cycle conferences. He is fluent in English, German and French.

This course is addressed to those working in regulatory processes of Medical Device companies: Regulatory Affairs, Clinical Operations, Quality Assurance 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 interactive lectures and case studies discussion.
Delegates will have the opportunity to bring their own cases and have their regulatory strategy assessed.

The training course will take place in Budapest

Additional information about the venue will be available soon

Brochure
Certificate of attendance

Early Bird: € 880,00* (until 07 May 2020)

Ordinary: € 990,00*

Freelance - Academy - Public Administration**: € 490,00*


*
for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.

Register now

Course Price

990.00 €

Early Bird

Thursday, May 7, 2020

880.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1 day

Course Type

Limited number of partecipants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Develop an effective strategy to obtain product approvals on a global scale

  • Design robust medical device registration steps in the Americas, Asia Pacific and China

  • Get insight on latest developments

Participants' Feedbacks

International and multidisciplinary profile of participants, which enriches the training

Availability and competence of the lecturer

International and multidisciplinary profile of participants, which enriches the training

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

Variety of topics covered, which have been adapted to the different needs of the participants

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Medical Devices Registration at an International Level

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
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Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities.

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