Invitation to a workshop on SAHPRA’s adoption of the European Medicines Agency (EMA) variation class


Dear industry stakeholders​

This email serves as an invitation to a workshop on SAHPRA’s adoption of the European Medicines Agency (EMA) variation classification guideline, which is aligned to the framework of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The briefing is to held on 16 April 2019.

Please note that this invitation is valid for only one representative from each company.

Please RSVP to this email by Thursday 11 April indicating the name, surname and email address of the representative who will attend. Due to space constraints no other attendees will be admitted to the workshop.

During the 2 hours session, we will discuss the key elements of the EMA variation classification guideline as well as the implementation roadmap. We will ensure there is sufficient time for questions at the end of the briefing.

Details of the briefing are below:

  • Date: 16 April 2019

  • Time: 2pm

  • Location: CSIR Building 22 (Central Station). Note: Please bring your South African ID, driver’s licence or passport to pass through security. Limited car parking will be available.

Documents to your perusal are:

We look forward to meeting you on 16th April.

Sincerely,

Davis Mahlatji

Head, Backlog Clearance Program

SAHPRA​

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