Registration closes on the 19 February 2019. Book your space today!

A First for South Africa: Open to All Individuals

Presentations to be conducted by representatives from the Regulatory Authorities:

Ghana FDA, Kenya PPB, Nigeria NAFDAC, Uganda NDA & Eastern African Community Medicines Regulatory Harmonization (EAC MRH) Programme:

• Mrs Delese Afia Amoakoa Mimi Darko nee Osei-Bonsu

Chief Executive Ghana Food and Drugs Board

• Mr Dominic Munyoroku Kariuki

Directorate of products evaluation and registration at Pharmacy and Poisons Board in Kenya

• Dr Mojisola Christianah Adeyeye

Director-General at National Agency for Food and Drug Administration and Control in Nigeria

• Ms Donna Asiimwe Kusemererwa

Secretary to the Authority of National Drug Authority in Uganda

• Mr Mwesigye John Patrick

Senior Health Officer at East African Community (EAC) Secretariat responsible for Medicines Regulatory Harmonization (MRH) Programme

Content to be discussed at this seminar:

• Requirements for product registration: Medicine/ medical device/ complementary medicines dossier requirements

• Relevant guidelines

• Fees required

• Samples

• Labelling requirements and languages

• Post importation: Laboratory testing of product/batches - where, when and how often?

• GXP inspections

• Pre- & post-registration variations

• Harmonisation initiatives and processes to register products under joint procedures

• Tender market/import/export - Regulatory dossier requirements

• Pharmacovigilance

• Counterfeit management

Why you should attend?

• Queries regarding product entrance into these emerging markets will be addressed.

• Brush shoulders with esteemed experienced Regulatory Authority professionals who are directly involved in product registration.

• Capitalise on the opportunity to address the speakers directly with our interactive Q&A sessions.

• Each attendee will receive a course pack containing comprehensive documentation which will be a valuable source of reference.

Who should attend?

This seminar will be of interest to pharmaceutical, medical device and complementary medicine companies and

individuals who need to learn about successful product applications and registration in Ghana, Kenya, Nigeria,

Uganda & understand the EAC MRH Programme.

Steps to register:

1) Choose the quantity of seats you want (delegates can only book more than 1 seat if from the same company), and then click the “checkout” button.

2) Enter personal information and then click the “confirm & proceed” button.

3) You will then be directed to a page reflecting the Twinz Foundation banking details (note that payments can only be processed thought EFT and once you receive an invoice).

4) Click the “buy now” button to finalise registration.

5) Once you have completed steps 1 to 6, you will receive, via email, a booking confirmation ticket and shortly thereafter an invoice.

6) Once you make payment, you will receive a valid ticket attendance.

Price includes lunch and refreshments for both days