FDAnews Announces Perfecting Your Company Core Data Sheets Webinar, Nov. 18
Falls Church, VA (PRWEB) November 11, 2013 -- Perfecting Your Company Core Data Sheets
A Guide for Authoring and Updating the CCDS
**FDAnews Webinar**
Nov. 18, 2013 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/CompanyCore
Can more than one drug name appear in a CCDS?
Who is the proper party to approve CCDS updates and revisions?
Are YOUR CCDS-writing skills in need of a brush-up?
Composing a Company Core Data Sheet (CCDS) is one of the toughest challenges facing drugmakers today.
Approved indications ... dosing requirements ... methods of administration ... concerns of special patient populations ... packaging and storage requirements and limitations ... incompatibilities and pharmacological properties — all must be in the CCDS, plus safety information.
The CCDS serves as the basis for prescribing a medication and for global advertising and promotional activities. In some countries, notably the U.S., promotional claims that do not conform to approved labeling can render the product misbranded.
It’s high time to sharpen CCDS-writing skills.
Register today for the webinar that helps with that — 90 minutes spent with one of the world’s top experts, consultant Graeme Ladds of PharSafer®.
On Monday, Nov. 18, Mr. Ladds will walk attendees step-by-step through:
• Essential elements every CCDS must have
• Updating and maintaining CCDSs — what’s working and what’s not
• What safety data should and should not be included in CCDSs
• Formatting the CCDS to satisfy international regulatory agencies and end-users
• How CCDSs can aid in adverse event reporting compliance
• The approval mechanism for a new and a revised CCDS
• Which departments and committees should be responsible for editing CCDSs
• How to manage these teams and their sometimes opposing goals
• SOP language that can improve CCDS writing and editing efforts
• Clarification of U.S. and new EU and global rules on safety data reporting
• Tips for avoiding typical CCDS pitfalls
• And much more
How frequently should a CCDS be updated? Discover answers on Monday, Nov. 18.
Is it wiser to start a CCDS early in the drug development process, or wait until initial submissions are in preparation? Mr. Ladds shows the correct course of action.
Can more than one drug name appear in a CCDS? If only one country's regulators require a labeling change, must the CCDS reflect that? Where in the CCDS should disposal considerations and other safe handling requirements be reported?
Find out — Sign up today.
MEET YOUR PRESENTER
Graeme Ladds is CEO of PharSafer®. Previously, he was chief of global drug safety for a multinational pharma company. An EU Qualified Person for Pharmacovigilance (EU QP PV), Mr. Ladds has worked as both a pharmacovigilance and medical information manager. He is the author of A Guide to Global Pharmacovigilance (2006, updated 2010) as well as many articles on pharmacovigilance in peer-reviewed journals. He currently serves as editor on a multinational pharmacovigilance journal. In 2005, Mr. Ladds and a global safety database provider designed a validated global medical information database that links directly to the safety database, providing seamless transfer of ADRs as well as a multifunctional medical services database.
WHO WILL BENEFIT
Here’s a suggested list of potential participants:
• Pharmacovigilance and drug safety personnel and managers
• CCDS writers and reviewers
• Medical affairs/medical monitors and physicians
• Compliance officers
• Consultants/service providers
• Executive management
• General/corporate counsel
• Personnel new to drug safety and pharmacovigilance
• QA/QC personnel
• Regulatory/legislative affairs personnel
• Drug safety scientists/risk management specialists
• Marketing authorization holders
• Training personnel
Conference Details
Perfecting Your Company Core Data Sheets
A Guide for Authoring and Updating the CCDS
**FDAnews Webinar**
Nov. 18, 2013 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/CompanyCore
Tuition
$547 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register
Online: http://www.fdanews.com/CompanyCore
By phone: 888-838-5578 or 703-538-7600
ABOUT FDANEWS
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDANEWS, http://www/fdanews.com/CompanyCore, +1 (703) 538-7665, [email protected]
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