FORUM INSTITUT
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Course The Person Responsible for Regulatory Compliance
The Person Responsible for
Regulatory Compliance
2020-05-14 2020-05-14 Holiday Inn Leiden Haagse Schouwweg 10 2332 KG Amsterdam / Leiden +31(0) 71 535 5555 +31(0) 71 53 55 553

The Person Responsible for Regulatory Compliance

The MDR and new responsibilities and challenges for medical device companies

How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and more in our seminar!
Topics
  • Legal and regulatory requirements for the PRRC in Europe
  • Interfaces within the company
  • Effective preparation and practical challenges
  • Audit and compliance readiness
  • Liability risk for the PRRC and manufacturer

Aims and objectives

Since the publication of the new EU regulatory framework for medical devices, many innovations need to be implemented. One of them is the person responsible for regulatory compliance (PRRC). This 'responsible person' has important tasks and responsibilities, which, together with liability risk, will be discussed in detail in this seminar. How must the responsibilities be defined? What are the internal interfaces? What preparation is required for this new role? Our seminar will address precisely these questions and show you how to make the necessary preparations. Our team of experts will give you practical tips on how to meet the upcoming challenges and explain the most important issues in practice.
Who should attend
This seminar is aimed at managers as well as qualified and responsible people in medical device and pharmaceutical companies, as well as participants aspiring to this role, particularly those in the following departments:
  • Vigilance and Regulatory Affairs;
  • Quality Assurance and Management; and
  • Management and Law.
Your speakers
Dr. Dr. Adem Koyuncu
Law firm Covington & Burling LLP, Brussels & Frankfurt

Dr. iur. Arkan Zwick
CROMA PHARMA GmbH, Leobendorf, Austria


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