When: 11 May 2021, 11.00-12.00 BST
Overview
With an estimated market potential of 65 billion US$, the African pharmaceutical market offers significant opportunity to companies keen on market expansion, and coupled with the increase in number of African countries with significantly improved regulatory control, opens this market up to manufacturers from highly regulated markets. This webinar will provide the attendee with a high-level operational understanding of the medicine and related products regulatory landscape in South Africa and Southern Africa, with a focus on well-regulated, Anglophone countries.
Learning objectives
By engagement in this webinar, the delegate will:
- Have an understanding of the overall regulatory requirements for business presence in the region
- Have an understanding of the various national platforms as well as regional collaborative platforms available to access regulated markets
- Have an understanding of the timelines and associated costs relating to medicine and related product regulatory activity
- Be exposed to the regulation relating to new medicines – NCE, Biological, Generic-, medical devices, complementary medicines (including health supplements), veterinary medicines and associated animal health products, with a focus on unique expectations
- Have an understanding of requirements and timelines to effect variations in-market
- Have an understanding of GMP expectations in the region
Target Audience
This webinar is suitable for all Regulatory Affairs personnel across all sectors of the pharmaceutical market wanting a high-level overview of regulated market access to Southern Africa.
Speaker
Dineshree Naiker (B.Pharm.)
Dineshree is a senior pharmaceutical industry executive with over 22 years of strategic and operational leadership experience within the South African pharmaceutical industry, with experience in regulatory affairs, quality management, supply chain and general management.
In the last 14 years, Dineshree is Partner and Co-founder of KD CONSULTING PHARMACEUTICAL SOLUTIONS (KDC), a specialised pharmaceutical consulting practice delivering regulatory affairs, quality assurance, risk management, pharmacovigilance and compliance services and solutions, through robust scientific approach, backed by professional service delivery and over a decade of consulting experience across Southern Africa. Dineshree’s vision is to make a positive contribution to healthcare delivery in Southern Africa, with a drive for social change, a personal focus on addressing unmet medical needs together with the delivery of quality healthcare for all in an ethical and sustainable way.
Dineshree has extensive working knowledge of the South African and Sub-Saharan African regulatory and distribution landscape, across a vast number of therapeutic areas and types of health products, with the demonstrated know-how on how to strategically and successfully access these markets and has a well-established, healthy relationship with the regulatory authorities in the region.
Dineshree is an experienced pharmaceutical auditor with extensive quality management and regulatory compliance experience across both large multinational pharmaceutical environments and more recently, start-ups. Prior to co-founding KD Consulting, Dineshree held the positions of Director (Pharmaceutical) at Intervet (Pty) Ltd, the South African subsidiary of the then Dutch multinational veterinary pharmaceutical company, now MSD Animal Health (Pty) Ltd, for a period of 10 years.
CPD
This course offers 1 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.
How do I register?
Prices
| Type |
Member |
Non-member |
| Standard |
£70 + VAT |
£95 + VAT |
Discounted Places
A limited number of discounted places are available at the rates below for those:
Please email meetings@topra.org for a discount code before making your booking.
| Type |
Member |
Non-member |
| Discount |
£35 + VAT* |
£47.50 + VAT* |
* VAT, if applicable, is charged at a rate of 20%.
Terms and conditions
By purchasing this webinar, you are agreeing to the terms and conditions.