public webpage on summary of product characteristics smpc
play

Public webpage on summary of product characteristics (SmPC) - PowerPoint PPT Presentation

Feb 07, 2023 •226 likes •285 views

Public webpage on summary of product characteristics (SmPC) PCWP-HCP WG joint meeting, 28 February 2012 Laurent Brassart Medical Information Information Compliance and Consistency An agency of the European Union Background

  1. Public webpage on summary of product characteristics (SmPC) PCWP-HCP WG joint meeting, 28 February 2012 Laurent Brassart Medical Information – Information Compliance and Consistency An agency of the European Union

  2. Background • Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations (10/ 07/ 2009) – To optimise regulatory information • SmPC Guideline implementation plan • Revision of the template of package leaflet • EPAR usability project – To inform about the role of the regulatory authorities (e.g. where to find information on benefits and risks, where data come from) • Involvement of Patients and Healthcare Professionals Organisations in the review of SmPC and package leaflet 1

  3. SmPC implementation plan A cost-effective tool to facilitate harmonised review of SmPC within the regulatory network 2

  4. Why a public access to the webpage? • Share training material with pharmaceutical industry • Support Healthcare Professional or Patients Organisations’ involvement in the review of SmPC or Package leaflet • Increase HCPs’ knowledge on SmPC • Contribute to public awareness of regulatory information 3

  5. Future public webpage • Same content as EudraSmPC webpage except Query&Answer system which supports regulatory review process. – Update of training presentations + on-demand webinars • New presentations: – “SmPC: what is it and what does it contain?” – A draft presentation is being circulated for your input – Future presentations • Package Leaflet • Elderly population and SmPC information • Other suggestions? 4

Download Presentation
Download Policy: The content available on the website is offered to you 'AS IS' for your personal information and use only. It cannot be commercialized, licensed, or distributed on other websites without prior consent from the author. To download a presentation, simply click this link. If you encounter any difficulties during the download process, it's possible that the publisher has removed the file from their server.

Recommend

Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the

Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the

Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the European Union Table of contents 1.What is the summary of product 7. Information on the risks of the characteristics (SmPC)? medicine 2.Where

702 views • 31 slides
Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the

Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the

Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the European Union Table of contents 1.What is the summary of product 7. Information on the risks of the characteristics (SmPC)? medicine 2.Where

609 views • 32 slides
0 The Summary of Product Characteristics (or SmPC) is the most important regulatory document on a

0 The Summary of Product Characteristics (or SmPC) is the most important regulatory document on a

This video has been prepared by the SmPC AG and consists in a general introduction to the Summary of Product Characteristics 0 The Summary of Product Characteristics (or SmPC) is the most important regulatory document on a medicinal product in

234 views • 7 slides
Section 1: Name of medicinal product SmPC training presentation Note : for full information

Section 1: Name of medicinal product SmPC training presentation Note : for full information

Section 1: Name of medicinal product SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European Union Index

492 views • 7 slides
Pharmacogenomics information in SmPC SmPC training presentation Note : for full information

Pharmacogenomics information in SmPC SmPC training presentation Note : for full information

Pharmacogenomics information in SmPC SmPC training presentation Note : for full information refer to the European Commission's Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European Union Index I.

426 views • 19 slides
SmPC and older people SmPC training presentation Note : for full information refer to the

SmPC and older people SmPC training presentation Note : for full information refer to the

SmPC and older people SmPC training presentation Note : for full information refer to the European Commission's Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European Union Index I. Introduction

1.37k views • 24 slides
SmPC of fixed combination medicinal products SmPC training presentation Note : for full

SmPC of fixed combination medicinal products SmPC training presentation Note : for full

SmPC of fixed combination medicinal products SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European Union

531 views • 28 slides
Section 4.5: Interaction with other medicinal products and other forms of interaction SmPC

Section 4.5: Interaction with other medicinal products and other forms of interaction SmPC

Section 4.5: Interaction with other medicinal products and other forms of interaction SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC

334 views • 20 slides
Introduction to the SmPC guideline SmPC training presentation Note : for full information refer

Introduction to the SmPC guideline SmPC training presentation Note : for full information refer

Introduction to the SmPC guideline SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European Union Table of

728 views • 10 slides
Section 4.2: Posology and method of administration Rev. 1 SmPC training presentation Note :

Section 4.2: Posology and method of administration Rev. 1 SmPC training presentation Note :

Section 4.2: Posology and method of administration Rev. 1 SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the

938 views • 55 slides
Section 4.7: Effects on the ability to drive and use machines SmPC training presentation Note :

Section 4.7: Effects on the ability to drive and use machines SmPC training presentation Note :

Section 4.7: Effects on the ability to drive and use machines SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of

341 views • 12 slides
Section 4.1: Therapeutic indications Rev.1 SmPC training presentation Note : for full

Section 4.1: Therapeutic indications Rev.1 SmPC training presentation Note : for full

Section 4.1: Therapeutic indications Rev.1 SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European Union

329 views • 21 slides
Section 5.1: Pharmacodynamic properties Rev. 1 SmPC training presentation Note : for full

Section 5.1: Pharmacodynamic properties Rev. 1 SmPC training presentation Note : for full

Section 5.1: Pharmacodynamic properties Rev. 1 SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European

517 views • 35 slides
Section 6: Pharmaceutical particulars Rev. 1 SmPC training presentation Note : for full

Section 6: Pharmaceutical particulars Rev. 1 SmPC training presentation Note : for full

Section 6: Pharmaceutical particulars Rev. 1 SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European

580 views • 36 slides
Section 5.2: Pharmacokinetic properties Rev. 1 SmPC training presentation Note : for full

Section 5.2: Pharmacokinetic properties Rev. 1 SmPC training presentation Note : for full

Section 5.2: Pharmacokinetic properties Rev. 1 SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European

725 views • 37 slides
Section 4.8: Undesirable effects Rev. 1 SmPC training presentation Note : for full information

Section 4.8: Undesirable effects Rev. 1 SmPC training presentation Note : for full information

Section 4.8: Undesirable effects Rev. 1 SmPC training presentation Note : for full information refer to the European Commissions Guideline on summary of product characteristics (SmPC) SmPC Advisory Group An agency of the European Union

730 views • 49 slides
National Grid Webinars Feedback Q1: Did you find the webinars useful? Question1. Website

National Grid Webinars Feedback Q1: Did you find the webinars useful? Question1. Website

National Grid Webinars Feedback Q1: Did you find the webinars useful? Question1. Website Information The NTS Operation webinar took place on 11th September NTS Operation and was led by Dan Treverton, the Principal Operations Strategy

554 views • 7 slides
Project Plan GameChang3rs Learning Management System The Capstone Experience Team Michael

Project Plan GameChang3rs Learning Management System The Capstone Experience Team Michael

Project Plan GameChang3rs Learning Management System The Capstone Experience Team Michael Sadler Foundation Ahmad Bazzi Sam Liao Cody Mohr Hannah Wood Department of Computer Science and Engineering Michigan State University Fall 2019

347 views • 12 slides
Technology Advisory Committee (TAC) Report to the Board of Education Fremont Unified School

Technology Advisory Committee (TAC) Report to the Board of Education Fremont Unified School

Technology Advisory Committee (TAC) Report to the Board of Education Fremont Unified School District August 17 , 2016 Rebecca Muoz Smith, TAC Chair for 2014 2015 Jeff Downing, TAC Chair for 2015 2016 Joseph Siam, Chief Technology Officer,

571 views • 9 slides
COIT Budget & Performance Subcommittee Regular Meeting December 7, 2018 1 Dr. Carlton B.

COIT Budget & Performance Subcommittee Regular Meeting December 7, 2018 1 Dr. Carlton B.

COIT Budget & Performance Subcommittee Regular Meeting December 7, 2018 1 Dr. Carlton B. Goodlett Place, City Hall, Room 305 San Francisco, CA 94102 1 Agenda Call to Order by Chair Roll Call Approval of Meeting Minutes

921 views • 43 slides
Community Engagement #2 July 27 August 3, 2020 101 12 th Street South Site Plan Amendment,

Community Engagement #2 July 27 August 3, 2020 101 12 th Street South Site Plan Amendment,

Community Engagement #2 July 27 August 3, 2020 101 12 th Street South Site Plan Amendment, New Site Plan, Rezoning 101 12 th Street South Project Webpage: https://projects.arlingtonva.us/projects/101-12th-st-s/ Presentation Outline

305 views • 19 slides
Web Portal Access Caughlin Ranch Homeowners Association is pleased to announce the arrival of our

Web Portal Access Caughlin Ranch Homeowners Association is pleased to announce the arrival of our

Web Portal Access Caughlin Ranch Homeowners Association is pleased to announce the arrival of our Association Web Portal Access! For your convenience, you may now go online to access your account information, forms or other information that

197 views • 17 slides
Build your own Web Portal using OpenStack APIs and Services OpenStack Summit in Austin 2016

Build your own Web Portal using OpenStack APIs and Services OpenStack Summit in Austin 2016

Build your own Web Portal using OpenStack APIs and Services OpenStack Summit in Austin 2016 April 27, 2016 IBM Japan Systems Engineering Co.,Ltd. Machi Hoshino OpenStack Summit in Austin 2016 Outline Introduction What is OpenStack

685 views • 42 slides
Wyoming Medicaid Web Portal Billing http://wyequalitycare.acs- inc.com/provider_home.html

Wyoming Medicaid Web Portal Billing http://wyequalitycare.acs- inc.com/provider_home.html

Wyoming Medicaid Web Portal Billing http://wyequalitycare.acs- inc.com/provider_home.html ADVANTAGES T TO W O WEB B POR ORTAL BI BILLING Eliminate paper billing Faster payments Better claim tracking Saved templates Log Into

893 views • 41 slides

More recommend