Everand Logo

Welcome to Everand!

  • Discover millions of ebooks, audiobooks, and so much more with a free trial

    From $11.99/month after trial. Cancel anytime.

    Pharmacovigilance A Complete Guide - 2019 Edition
    Pharmacovigilance A Complete Guide - 2019 Edition
    Pharmacovigilance A Complete Guide - 2019 Edition
    Ebook209 pages1 hour

    Pharmacovigilance A Complete Guide - 2019 Edition

    By Gerardus Blokdyk

    ()

    Read preview

    About this ebook

    Do you have the technical facilities and capacities (fax, email, internet)? Could this be an allergy? Are there any requirements concerning the role of the sponsor if the trial is initiated by an overseas institution? Changing prescribing in the light of tolerability concerns: How is this best achieved? Do you provide by default a monitoring manual / plan?

    This powerful Pharmacovigilance self-assessment will make you the dependable Pharmacovigilance domain standout by revealing just what you need to know to be fluent and ready for any Pharmacovigilance challenge.

    How do I reduce the effort in the Pharmacovigilance work to be done to get problems solved? How can I ensure that plans of action include every Pharmacovigilance task and that every Pharmacovigilance outcome is in place? How will I save time investigating strategic and tactical options and ensuring Pharmacovigilance costs are low? How can I deliver tailored Pharmacovigilance advice instantly with structured going-forward plans?

    There’s no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Pharmacovigilance essentials are covered, from every angle: the Pharmacovigilance self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that Pharmacovigilance outcomes are achieved.

    Contains extensive criteria grounded in past and current successful projects and activities by experienced Pharmacovigilance practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Pharmacovigilance are maximized with professional results.

    Your purchase includes access details to the Pharmacovigilance self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria:

    - The latest quick edition of the book in PDF

    - The latest complete edition of the book in PDF, which criteria correspond to the criteria in...

    - The Self-Assessment Excel Dashboard

    - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

    - In-depth and specific Pharmacovigilance Checklists

    - Project management checklists and templates to assist with implementation

    INCLUDES LIFETIME SELF ASSESSMENT UPDATES

    Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

    LanguageEnglish
    Publisher5STARCooks
    Release dateDec 21, 2018
    ISBN9780655568025
    Pharmacovigilance A Complete Guide - 2019 Edition

    Read more from Gerardus Blokdyk

    Related to Pharmacovigilance A Complete Guide - 2019 Edition

    Related ebooks

    Business For You

    View More
    View More

    Related podcast episodes

    Related articles

    • UNLIMITED

      How To Reduce Medical Errors

      Nov 16, 2019

      In 1999, the Institute of Medicine—an organization regarded as an authority at the intersection of medicine and society—published a report, “To Err Is Human,” which found that up to 98,000 Americans were dying annually from medical errors. Twenty yea

      3 min read

    • UNLIMITED

      Getting To The Root Of The Problem: Using The Five Whys Method

      Feb 25, 2018

      The University of Sydney’s Dr Martin Tomitsch, co-author of the book Design. Think. Make. Break. Repeat. says a helpful exercise for facility managers is the five whys method, which came out of the auto industry to identify the root cause of problems

      1 min read

    • UNLIMITED

      Expanding Precision Medicine

      Jul 30, 2020

      Expanding Precision Medicine
      9 min read

    • UNLIMITED

      Opinion: Data Standards May Be Wonky, But They Will Transform Health Care

      Oct 3, 2019

      The World Wide Web was born when Tim Berners-Lee created a few specifications that were codified by a global consortium. Creating specifications for data standards could similarly revolutionize health care.

      5 min read

    • UNLIMITED

      Measuring Digital Innovation: A Four-Stage Framework

      May 1, 2024

      THE DIGITAL ERA DEMANDS INNOVATION. Every business today — indeed, every organization — must continually adapt to keep up with changing customer expectations, new digital competitors and business models made possible by emerging technologies. For an

      8 min read

    • UNLIMITED

      Nail Your Dream Job

      Jul 28, 2021

      Nail Your Dream Job
      7 min read

    • UNLIMITED

      Grow Your Remote Business

      Jun 30, 2020

      Grow Your Remote Business
      4 min read

    • UNLIMITED

      Building Your Reputation, Online And Off

      Apr 20, 2022

      When you’re asked to name a good dentist, café, mechanic or any other kind of business, you’re being asked to stake your reputation against a previous experience. This happened recently in my neighbourhood’s online group. Someone asked for a good bui

      2 min read

    • UNLIMITED

      3 Ways to Increase the Enterprise Value of Your Family Business

      Aug 31, 2022

      Many entrepreneurs focus on revenue, innovation and people to lead their enterprise forward in the future – but business tends to get in the way.  Finding, recruiting and hiring talent, maintaining relationships with key customers and vendors, dealin

      3 min read

    • UNLIMITED

      4 Steps to Leadership

      Sep 1, 2022

      4 Steps to Leadership
      3 min read

    • UNLIMITED

      4 Steps to Effectively Transition or Sell Your Business

      Jun 17, 2019

      Did you know 70% to 80% of middle-market, closely held businesses put on the market do not sell? And 83% of businesses lack a formal, written transition plan? I've had many discussions with middle-market business owners about planning for the future

      3 min read

    • UNLIMITED

      Kim Adams

      Feb 9, 2023

      Got a query? [email protected] HOW TO Understand our tests OVER the next few pages you will see several star ratings. There are even more across the Auto Express website, where we have a huge archive of product tests going back more than a d

      1 min read

    • UNLIMITED

      Q&A

      May 1, 2023

      Describe the capability that companies like Netflix, UPS, Amazon and Caesars Entertainment have in common. These are all leading firms in their industries with respect to leveraging analytics as a source of competitive advantage. We now have so much

      7 min read

    • UNLIMITED

      9 Complete Guide: 8 Mistakes You Must Avoid In Your Content Marketing Campaign In 2020

      Nov 30, 2020

      Complete Guide: 8 mistakes you must avoid in your content marketing campaign in 2020 Content being the king of all marketing activities worldwide, content marketing has gained popularity over time as one of the best investments a brand can make. It’s

      14 min read

    • UNLIMITED

      The Usual Suspects

      Aug 12, 2018

      The Usual Suspects
      2 min read

    • UNLIMITED

      Reach Your Customers!

      Mar 31, 2020

      Reach Your Customers!
      10 min read

    Related categories

    Reviews for Pharmacovigilance A Complete Guide - 2019 Edition

    0 ratings

    0 ratings0 reviews

    What did you think?

    Tap to rate

    Review must be at least 10 words

      Book preview

      Pharmacovigilance A Complete Guide - 2019 Edition - Gerardus Blokdyk

      Pharmacovigilance

      Complete Self-Assessment Guide

      The guidance in this Self-Assessment is based on Pharmacovigilance best practices and standards in business process architecture, design and quality management. The guidance is also based on the professional judgment of the individual collaborators listed in the Acknowledgments.

      Notice of rights

      You are licensed to use the Self-Assessment contents in your presentations and materials for internal use and customers without asking us - we are here to help.

      All rights reserved for the book itself: this book may not be reproduced or transmitted in any form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

      The information in this book is distributed on an As Is basis without warranty. While every precaution has been taken in the preparation of he book, neither the author nor the publisher shall have any liability to any person or entity with respect to any loss or damage caused or alleged to be caused directly or indirectly by the instructions contained in this book or by the products described in it.

      Trademarks

      Many of the designations used by manufacturers and sellers to distinguish their products are claimed as trademarks. Where those designations appear in this book, and the publisher was aware of a trademark claim, the designations appear as requested by the owner of the trademark. All other product names and services identified throughout this book are used in editorial fashion only and for the benefit of such companies with no intention of infringement of the trademark. No such use, or the use of any trade name, is intended to convey endorsement or other affiliation with this book.

      Copyright © by The Art of Service

      http://theartofservice.com

      [email protected]

      About The Art of Service

      The Art of Service, Business Process Architects since 2000, is dedicated to helping stakeholders achieve excellence.

      Defining, designing, creating, and implementing a process to solve a stakeholders challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department.

      Unless you’re talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions.

      Someone capable of asking the right questions and step back and say, ‘What are we really trying to accomplish here? And is there a different way to look at it?’

      With The Art of Service’s Standard Requirements Self-Assessments, we empower people who can do just that — whether their title is marketer, entrepreneur, manager, salesperson, consultant, Business Process Manager, executive assistant, IT Manager, CIO etc... —they are the people who rule the future. They are people who watch the process as it happens, and ask the right questions to make the process work better.

      Contact us when you need any support with this Self-Assessment and any help with templates, blue-prints and examples of standard documents you might need:

      http://theartofservice.com

      [email protected]

      Acknowledgments

      This checklist was developed under the auspices of The Art of Service, chaired by Gerardus Blokdyk.

      Representatives from several client companies participated in the preparation of this Self-Assessment.

      In addition, we are thankful for the design and printing services provided.

      Included Resources - how to access

      Included with your purchase of the book is the Pharmacovigilance Self-Assessment Spreadsheet Dashboard which contains all questions and Self-Assessment areas and auto-generates insights, graphs, and project RACI planning - all with examples to get you started right away.

      How? Simply send an email to

      [email protected]

      with this books’ title in the subject to get the Pharmacovigilance Self Assessment Tool right away.

      You will receive the following contents with New and Updated specific criteria:

      •The latest quick edition of the book in PDF

      •The latest complete edition of the book in PDF, which criteria correspond to the criteria in...

      •The Self-Assessment Excel Dashboard, and...

      •Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

      •In-depth specific Checklists covering the topic

      •Project management checklists and templates to assist with implementation

      INCLUDES LIFETIME SELF ASSESSMENT UPDATES

      Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

      Get it now- you will be glad you did - do it now, before you forget.

      Send an email to [email protected] with this books’ title in the subject to get the Pharmacovigilance Self Assessment Tool right away.

      Your feedback is invaluable to us

      If you recently bought this book, we would love to hear from you!

      You can do this by writing a review on amazon (or the online store where you purchased this book) about your last purchase! As part of our continual service improvement process, we love to hear real client experiences and feedback.

      How does it work?

      To post a review on Amazon, just log in to your account and click on the Create Your Own Review button (under Customer Reviews) of the relevant product page. You can find examples of product reviews in Amazon. If you purchased from another online store, simply follow their procedures.

      What happens when I submit my review?

      Once you have submitted your review, send us an email at

      [email protected] with the link to your review so we can properly thank you for your feedback.

      Purpose of this Self-Assessment

      This Self-Assessment has been developed to improve understanding of the requirements and elements of Pharmacovigilance, based on best practices and standards in business process architecture, design and quality management.

      It is designed to allow for a rapid Self-Assessment to determine how closely existing management practices and procedures correspond to the elements of the Self-Assessment.

      The criteria of requirements and elements of Pharmacovigilance have been rephrased in the format of a Self-Assessment questionnaire, with a seven-criterion scoring system, as explained in this document.

      In this format, even with limited background knowledge of Pharmacovigilance, a manager can quickly review existing operations to determine how they measure up to the standards. This in turn can serve as the starting point of a ‘gap analysis’ to identify management tools or system elements that might usefully be implemented in the organization to help improve overall performance.

      How to use the Self-Assessment

      On the following pages are a series of questions to identify to what extent your Pharmacovigilance initiative is complete in comparison to the requirements set in standards.

      To facilitate answering the questions, there is a space in front of each question to enter a score on a scale of ‘1’ to ‘5’.

      1 Strongly Disagree

      2 Disagree

      3 Neutral

      4 Agree

      5 Strongly Agree

      Read the question and rate it with the following in front of mind:

      ‘In my belief,

      the answer to this question is clearly defined’.

      There are two ways in which you can choose to interpret this statement;

      1.how aware are you that the answer to the question is clearly defined

      2.for more in-depth analysis you can choose to gather evidence and confirm the answer to the question. This obviously will take more time, most Self-Assessment users opt for the first way to interpret the question and dig deeper later on based on the outcome of the overall Self-Assessment.

      A score of ‘1’ would mean that the answer is not clear at all, where a ‘5’ would mean the answer is crystal clear and defined. Leave emtpy when the question is not applicable or you don’t want to answer it, you can skip it without affecting your score. Write your score in the space provided.

      After you have responded to all the appropriate statements in each section, compute your average score for that section, using the formula provided, and round to the nearest tenth. Then transfer to the corresponding spoke in the Pharmacovigilance Scorecard on the second next page of the Self-Assessment.

      Your completed Pharmacovigilance Scorecard will give you a clear presentation of which Pharmacovigilance areas need attention.

      Pharmacovigilance

      Scorecard Example

      Example of how the finalized Scorecard can look like:

      Enjoying the preview?
      Page 1 of 1