; Online-Course The Person Responsible for Regulatory Compliance
2022-03-22 2022-03-22 , Online Online, 1.090,- € plus tax Dr. Dr. Adem Koyuncu https://www.forum-institut.com/seminar/22032491-the-person-responsible-for-regulatory-compliance/referenten/22/22_03/22032491-online-course-the-person-responsible-for-regulatory-compliance_koyuncu-adem.jpg The Person Responsible for Regulatory Compliance

How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and more in our online-seminar via Zoom!

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 online-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 online-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.

Online-Course The Person Responsible for Regulatory Compliance

The Person Responsible
for Regulatory Compliance

- Online training -

Benefits
  • Meet the experts!
  • The essentials in only one day!
  • Online format: Modern, flexible, interactive
  • We are following the IMI quality criteria

Webcode 22032491

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

22.03.2022

22.03.2022

Period

09:00-17:00 online-seminarThe times ...

09:00-17:00 online-seminar
The times for breaks at online-seminars are scheduled individually.
Venue

Online

Online

Downloads
Fee
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and more in our online-seminar via Zoom!

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 online-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 online-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.

Detailed programme

09:00-17:00 online-seminar
The times for breaks at online-seminars are scheduled individually.

09:00 Welcome and introduction round


09:15

Dr Dr Adem Koyuncu

The MDR 2017/745 and its impact
  • Regulation overview - major impacts
  • Key obligations and transition periods under the MDR
  • State of the implementation

09:45

Dr Dr Adem Koyuncu & Dr Arkan Zwick

Legal and regulatory requirements
  • Who needs a PRRC and when?
  • Organisational Integration, hierarchy and governance issues
  • Expertise and qualification requirements
  • Task and responsibilities
  • Conformity assessment of products
  • Technical documentation
  • Declaration for investigational products

11:00 Coffee break


11:15

Dr Arkan Zwick

Workshop: PRRC interfaces within the company
  • Marketing & sales: Art. 7: Claims
  • Production and quality
  • Clinical - limitations on equivalency and special procedures
  • Regulatory survey process; certification
  • R&D process: ensure compliance
  • National responsible person - how to organise collaboration
  • Delegation and deputising opportunities
  • Overview and practical challenges

12:45 Lunch break


13:30

Dr Arkan Zwick

Effective preparation and practical challenges
  • Are you prepared? What comes first? What follows?
  • Impact on labelling requirements
  • Handling off-label use
  • MDR implementation steps and instruments
  • PRRC implementation options
  • Required SOPs; adjusting internal processes
  • Audit and compliance readiness
  • Industry examples
  • Q&A

15:00 Coffee break


15:15

Dr Dr Adem Koyuncu & Dr Arkan Zwick

Liability risks for the PRRC, Manufacturers and Authorized Representatives
  • Legal framework under civil, criminal, labour and device law
  • MDR impact on liability risk
  • Manufacturer liability vs PRRC liability
  • Specific requirements for personal PRRC liability
  • Liability risk for manufacturers and legal representatives
  • Outsourcing, delegation and the impact on liability risk
  • Special practical cases on liability issues
  • Discussion of liability risk mitigation measures

16:45 Summary and outstanding questions


17:00 End of online training course


Further information

Assessment and certificate

You will have the opportunity to take a multiple-choice online test after the seminar. If you complete it successfully, you will receive a personalised certificate. We will send you the relevant access information by email after the seminar.

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

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Testimonials

Very informative event with very competent speakers.

Timo Bohnhoff

Diapharm GmbH & Co.KG