DUBLIN–(BUSINESS WIRE)–Jul 19, 2018–The “Pharmaceutical Regulatory Affairs in Africa” conference has been added to ResearchAndMarkets.com‘s offering.
Pharmaceutical Regulatory Affairs in Africa, including South Africa, Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Nigeria, Namibia, South Africa, Tanzania,Tunisia, Uganda, Zambia and Zimbabwe.
The aim of this seminar is to provide you with an understanding of the key areas of regulatory affairs in the region, a focus on the practical aspects to assist with regulatory activities. Also, the opportunity for you to participate in interactive discussions and exchange experiences with other delegates.
Topics to be covered at this meeting
Overview of the Regulatory Requirements within African countriesCompany and product registrationPractical information on Compiling DossiersHow to comply with Regulatory Submission StrategyRecent developments in South Africa
Who Should Attend:
This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and regulatory compliance in English speaking Africa. It will be useful as both an introductory or a refresher course on recent developments.
Agenda:
Introduction and welcome – General terms/dictionary
Harmonisation initiatives within Africa
The development of drug control
The regulatory authoritiesOther influences
Regulatory submission strategy
How to determine an appropriate submission strategyA practical approach
Company and product registration
Regulations and guidelinesNew products and line extensionsLabelling requirementsRegistration samples and certification/legalisation
Compilation of the dossiers
Contents and formatsHints on success/failureSpecific country requirements
Regulatory authority/agency assessment
ProcessTimelines
Recent developments in South Africa
Influences and changesComplementary and alternative medicines statusMedical devicesMarketing code for the advertising of medicines
For more information about this conference visit https://www.researchandmarkets.com/research/wcxnxp/pharmaceutical?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20180719005533/en/
CONTACT: ResearchAndMarkets.com
Laura Wood, Senior Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Drug Discovery
KEYWORD: UNITED KINGDOM EUROPE AFRICA
INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL
SOURCE: Research and Markets
Copyright Business Wire 2018.
PUB: 07/19/2018 10:32 AM/DISC: 07/19/2018 10:32 AM
Copyright Business Wire 2018.
