About Trainings

The objective of the MPP is to capitalize on the synergies between our industries by establishing a forum to exchange knowledge and collaborate in the arenas of technology, regulatory and build stakeholder consensus to promote product development and innovation.

To that aim, the MPP dispenses trainings throughout the year in addition to its annual meeting.

Target audience: professionals and individuals in the medtech and pharma sectors.

Topics: The topics are varied and cover broadly industry, regulatory as well as technical developments.

Course leaders: The trainings are given by topic experts.

Past Trainings

An overview of the vigilance requirements in the new MDR

Date and location: 27 July 2017, 3:00-4:00 PM CET, Online webinar

Objective: To provide a comprehensive overview of the vigilance requirements for medical devices in Europe under the new Medical Devices Regulation

Course leaders:

  • Conxita Barajas-Diaz, Head Drug Safety & Pharmacovigilance at SFL
  • Shayesteh Fürst-Ladani, President of the MPP Association

 

An overview of the upcoming MDR requirements

Date and location: 9 June 2017, 09:00-17:00, Basel

Objective: To provide a comprehensive overview of the regulatory system and requirements for medical devices in Europe under the new Medical Devices Regulation

Course leaders:

  • Theresa Jeary, Expert in Device Regulatory Affairs
  • Shayesteh Fürst-Ladani, President of the MPP Association

Agenda:

Introduction to the MDR

New CE certification process, including scrutiny mechanism for high risk devices

New stakeholders such as the MDCG

Clinical investigation, clinical evaluation, sources, and equivalence

Notified body selection considerations in the changing regulatory framework

Post-market clinical follow-up and surveillance requirements

New classification rules

Transparency requirements

Combination products in the EU - regulatory routes to the market

Timelines and transitional provisions

New conformity assessment requirements

 

 

An overview of the current MDD and future MDR requirements

Date and location: 25 April 2017, Basel

Objective: To provide a comprehensive overview of the regulatory system and requirements for medical devices in Europe from a current and future perspective

Course leader: Theresa Jeary, Expert in Device Regulatory Affairs

Agenda:

History of the Medical Device Directive

Classification changes and new rules

Combination products in the EU - Classification considerations and regulatory routes to market

CE Certification process under MDR incl. scrutiny process for high risk devices

Introduction to the MDR and key changes from the MDD

Clinical investigation and clinical evaluation, sources, equivalence

New players such as MDCG

Post-market clinical follow-up and surveillance requirements

Notified Body selection considerations resulting from the MDR publication

Transparency requirements

New conformity assessment requirements

An overview of the current IVDD and future IVDR requirements

Date & location: 26 April 2017, Basel

Objective: To provide a comprehensive overview of the regulatory system and requirements for in-vitro diagnostics in Europe from a current and future regulatory perspective

Course leaders:

  • Theresa Jeary, Expert in Device Regulatory Affairs
  • Shayesteh Fürst-Ladani, Expert in In-Vitro Diagnostics Policy

Agenda:

Overview of current IVDD requirements

Genetic counselling

The IVDR and key changes from the IVDD

Clinical performance requirements

Key stakeholders and new players

Requirements for companion diagnostics and role of drug competent authorities

Notified Body selection considerations

CE certification process under IVDR incl. scrutiny process for high risk devices

Classification changes

Post-market surveillance

New conformity assessment requirements

Transparency requirements

An overview of the current IVDD and future IVDR requirements

Date & location: 15 November 2016, Basel

Objective: To provide a comprehensive overview of the regulatory system and requirements for in-vitro diagnostics in Europe from a current and future regulatory perspective

Course leaders:

  • Theresa Jeary, Expert in Device Regulatory Affairs
  • Anna Hallersten, Expert in In-Vitro Diagnostics Policy

Agenda:

Overview of current IVDD requirements

Genetic counselling

The IVDR and key changes from the IVDD

Clinical performance requirements

Key stakeholders and new players

Requirements for companion diagnostics and role of drug competent authorities

Notified Body selection considerations

CE certification process under IVDR incl. scrutiny process for high risk devices

Classification changes

Post-market surveillance

New conformity assessment requirements

Transparency requirements

An overview of the current MDD and future MDR requirements

Date and location: 14 November 2016, Basel

Objective: To provide a comprehensive overview of the regulatory system and requirements for medical devices in Europe from a current and future perspective

Course leader: Theresa Jeary, Expert in Device Regulatory Affairs

 

Agenda:

History of the Medical Device Directive

Classification changes and new rules

Combination products in the EU - Classification considerations and regulatory routes to market

CE Certification process under MDR incl. scrutiny process for high risk devices

Introduction to the MDR and key changes from the MDD

Clinical investigation and clinical evaluation, sources, equivalence

New players such as MDCG

Post-market clinical follow-up and surveillance requirements

Notified Body selection considerations resulting from the MDR publication

Transparency requirements

New conformity assessment requirements

 

 

Overview of European Drug Regulatory Affairs

Date and location: 2 June 2016, Basel

Objective: To provide a comprehensive overview of the regulatory system and requirements for pharmaceuticals in Europe.

Course leaders:

  • Theresa Jeary, Expert in Device Regulatory Affairs
  • Serena Baldissera, Expert in Pharma Regulatory Affairs

Agenda:

Introduction to the European legislative framework

Product information: SmPC & PIL

Overview of authorization procedures

Lifecycle management, including pharmacovigilance, variations and renewals

Marketing authorization applications

 

Regulatory Framework for Combination Products

Date and location: 1 June 2016, Basel

Objective: To examine and instruct on the key regulatory aspects in combination products regulations.

Course leaders:

  • Theresa Jeary, Expert in Device Regulatory Affairs
  • Serena Baldissera, Expert in Pharma Regulatory Affairs

Agenda:

Classification of combination products

Consultation procedure for device & drug combination products

Overview of different types of combination products in Europe including regulatory pathways

Combination products law in the US

Clinical Evaluation of Medical Devices

Date and location: 1 June 2016, Basel

Objective: To provide a practical guide on the information needed to demonstrate clinical safety and performance of a medical device product in accordance with the requirements of the EU Medical Devices Directive.

Course leaders:

  • Theresa Jeary, Expert in Device Regulatory Affairs
  • Serena Baldissera, Expert in Pharma Regulatory Affairs

Agenda:

Understanding clinical evaluation

Preparing a clinical evaluation report

Clinical investigation with medical devices

PMCF and surveillance

 

 

European Medical Device Regulatory Affairs

Date and location: 31 May 2016, Basel

Objective: To provide a comprehensive overview of the regulatory system and requirements for medical devices in Europe.

Course leaders:

  • Theresa Jeary, Expert in Device Regulatory Affairs
  • Serena Baldissera, Expert in Pharma Regulatory Affairs

Agenda:

Introduction to EU Medical Device Law

Clinical evaluation

Risk classification of medical devices

Conformity assessment routes

Essential requirements

Vigilance, post-market surveillance