SAMED ANNUAL CONFERENCE 2017: ADVANCING QUALITY IN HEALTHCARE

Draft Programme CPD Point Allocation: 5 Clinical, 2 Ethics

TIME

08h30 Registration and welcome coffee/tea

09h00 Welcome by Dr Terence Moodley, SAMED Vice Chair

09h05 Opening address: Ms Malebona PreciousMatsoso, Director General, National Department of Health “South African Medical Device and IVD policy framework: ensuring only quality, safe and effective medical devices are used on patients” Please will you cover relevant policy frameworks that the South African government have implemented to ensure only quality medical devices enter the country. We would also like you to highlight any key lessons / learnings regarding this topic you have had from your engagement with the World Health Organisation.

09h40

10h00

South Africa’s new regulatory environment for Medical Devices and IVDs: Update and progress to date. How can Industry support the Regulator? Dr Joey Gouws, Registrar, Medicines Control Council Moderator: Anele Vutha, Vice-Chairperson, SAMED Regulatory Committee Panel discussion: Dr Joey Gouws, Registrar, Medicines Control Council: What has been the MCC’s experience been, in terms of the licences you have received from industry so far? What challenges are you currently experiencing in this process and how can industry assist? Avanthi Bester, Regulatory Affairs Manager, Becton Dickinson - Africa: Regarding the licence application process - how does the South African process compare to the rest of the continent? Have you applied for your licence? Was the process easy? Do you think there are areas of improvement? If so, what? How can industry support the MCC? Malan De Villiers, Managing Director, Southern Medical: As a local manufacturer, has it been easy to adapt your business to a regulated market? What pitfalls have you experienced? Are there any problems you have experienced that are unique to the local manufacturing industry? If so, are there any possible solutions?

10h30

Demystifying IS013485, role of South African Conformity Assessment Bodies and alignment with Medical Device and IVD Regulations Moderator: Anele Vutha, Vice-Chairperson, SAMED Regulatory Committee Panel Discussion: Dr Joey Gouws, Registrar, Medicines Control Council: What is the link between the IS013485/2016 system and the regulations? Why did the MCC choose this quality management system? When does the regulator expect companies to have finalised IS013485/2016 implementation? When will MCC start checking that companies have the Quality Management System? Tumelo Ledimo, Project Manager: Research & Development, SANAS: How and when will SANAS accredit Conformity Assessment bodies? Will there be a cost? What criteria will you use to assess conformity assessment bodies? Is the South African IS013485 system different from the European IS013485 system? If so, how? Does SABS have the capacity in order to accredit medical device companies to IS013485/2016? René Linde, Business Development Executive, BSI Group South Africa: In the IS013485 system, what aspects do distributors have to implement versus manufacturers? Are there some aspects that distributors can leave out? Will local manufacturers wishing to export have to be accredited twice, i.e. local and international? What is the cost for companies to implement it? Does the class of device you sell affect the parts of IS013485 you must implement? Iain Muir, Executive Director, Southern African Association of Certification Bodies: What distinguishes members of your organisation from non-members? How does a certification body become a member? Is there certain criteria they have to meet to be a member of SAACB?

11h10 Networking break

11h25

11h45

PS 2 - Roadmap for implementation of the Unique Device Identification (UDI) system. Introduction by Avanthi Bester What is the Unique Device Identification System? What are the benefits of implementing such a system in a country? What is the status of the UDI system in Europe and around the world? Moderator: Avanthi Bester, Chairperson, SAMED / SALDA Africa Committee Panel Discussion: Caroline Potgieter, E-Commerce Manager Procurement, Netcare (GS1 system): Why did Netcare implement the GS1 system? Is the GS1 System the same as the UDI system? Has it been a smooth transition? Is the GS1 system internationally recognized? How does the GS1 system ensure quality within Netcare hospitals? Gavin Steel, Chief Director: Sector Wide Procurement, National Department of Health: Do you think the UDI system is a viable option for South Africa? How does the NDoH procurement system currently track medical devices? Would the Department be able to set up an international database of all the barcoded devices?

PS 1 - Quality in Private and Public Hospitals. Successes and lessons learnt: Introduction by Prof Craig Househam Please can you describe what your organisation’s mission is? What have been your organisation’s current successes and achievements? Do any of your initiatives include looking at how procurement practices of medical devices impact Best Care? How can industry assist? Moderator: Professor Craig Househam, Health Management Consultant

Panel Discussion: Anita Hamilton, General Manager Procurement Services, Netcare: Why did Netcare make the CRICE initiative a requirement in all its hospitals? Has CRICE helped to improve the quality of care in your hospitals? How? Dr Rolene Wagner, CEO, Frere Hospital: How do you ensure that nurses and doctors trained properly on the use of medical devices in your hospital? What are some of the challenges your hospital faces with regard to quality of care and medical devices? Winnie Moleko, Executive Manager: Health Standards Design, Analysis & Support, Office of the Health Standards Compliance: What are the norms and standards the OHSC use to measure quality in healthcare facilities? What are the areas of major concern and what is being done to improve on them?

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12h15 Session shuffle

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PS 3 - Other legislation the Medical Device and IVD Industry must comply with. Moderator: Tanya Vogt, SAMED Executive Officer Advertising Standards Authority Code of Practice by Fred Makgato, Head: Legal & Regulatory Affairs, Advertising Standards Authority of South Africa (ASA) Please can you briefly outline the ASA Code of Practice and the powers of the ASA. What should the Medical Device Industry be aware of? What should companies adhere to? What are the penalties of transgressing the code? Current legislation applicable to Medical Device Companies when marketing their goods as well as the impact of Section 18(A)(B)(C) of the Medicine and Related Substances Act (as amended) by Neil Kirby, Director, Werksmans Attorneys. Please can you outline the Legislation that our companies should be aware of such as the POPI Act, The Consumer Protection Act etc?

PS 4 - The Changing Face of Public Procurement. Moderator: Professor Craig Househam, Health Management Consultant Update on Centralized procurement policy and PFMA/BBEE by Manthepeng Tshinavha, Director: Medical and Health Technology, Transversal Contracting Department, National Treasury. Please update industry on the implementation of National Treasury’s centralised procurement policy? Lessons learnt? How do you envisage the procurement of medical devices looking in the future? How can industry assist? Ensuring quality contracts with suppliers by Dr. Daniel Mokumo, Clinical Manager, WF Knobel Hospital, Limpopo How does your department ensure quality medical devices are procured? How are contracts with suppliers structured to enable quality after-sale service? Gauteng Department of Health’s sustainability plan to pay suppliers. Speaker to be confirmed

13h15 Lunch

14h00

PS 5 - Medical Device and IVD regulations for South Africa: What are the legal requirements and responsibilities of users and procurers including re-use of Single Use Devices by Andrea Julsing Keyter, Medicines Control Office, Medicines Control Council Moderator: Anele Vutha, Vice-Chairperson, SAMED Regulatory Committee Panel Discussion: Andrea Julsing Keyter, Medicines Control Office, Medicines Control Council Malakia Mashiloane, Chief Director: Supply Chain and Asset Management, Gauteng Department of Health What systems / initiatives has the Gauteng DoH implemented to ensure your facilities and staff align with the requirements of the regulations? Dr Mzukisi Grootboom,Chairperson, SAMA Have you communicated the regulations with your members? Do they have any concerns? How do you foresee that they will be able to abide by the regulations as they pertain to users?

PS 6 - Investing Globally Moderator: Avanthi Bester, Chairperson, SAMED / SALDA Africa Committee Doing business in Africa and the Regulatory Experiences by Brian Krawczyk, Director: Global Business Development, VIA Global Health via video Developing and Safeguarding the Local Medical Device Industry in Ireland by Natasha Siniscalchi, Senior Market Advisor, Enterprise Ireland

15h20 Networking break

15h40 Reporting Medical Device adverse events, what, how and when? Andrea Julsing Keyter, Medicines Control Office, Medicines Control Council Moderator: Tanya Vogt, SAMED Executive Officer

16h15 The Future is Freedom by Dawie Roodt, Chief Economist, Efficient Group Moderator: Tanya Vogt, SAMED Executive Officer

16h50 Closing remarks by Dr Terence Moodley, SAMED Vice Chair

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TIME

08h30 Registration and welcome coffee/tea

09h00 Welcome by Tanya Vogt, Executive Officer, SAMED

09h05 Opening address: Dr Millicent Simelane, Former Deputy Director General: Specialised Services & Clinical Support, KwaZulu-Natal Department of Health “The importance of ethical leadership in South Africa: key experiences and lessons learnt during my time in office” Please can you highlight experiences and lessons learnt during your time in office. What is needed to change the current healthcare system and the importance of ethical leadership in this process.

09h40 2016 South Africa’s Corruption Index: How can Industry work towards improving our rating? by David Lewis Executive Director, Corruption Watch (Transparency International, South Africa Chapter) Please share key findings from the latest Transparency International’s corruption index. What solutions need to be implemented to improve South Africa’s rating? Is there a role for industry in these solutions? If so, what can industry do to assist? Moderator: Marlon Burgess, SAMED Chair

10h10

Enforcing The MedTech Code by Roeland van Aelst, Regional Vice President: HCCO MD&D EMEA, Johnson & Johnson Please highlight the most common transgressions and give us examples of complaints. How were these handled? What were the sanctions? Moderator: Tanya Vogt, SAMED Executive Officer Panel Discussion: Roeland van Aelst , Regional Vice President: HCCO MD&D EMEA, Johnson & Johnson Nick Shalley, Independent Chair: Code Authority Committee, Medical Technology Association of Australia Howdoes MTAA deal with transgressions of their Code of Conduct? What is unique in the way you deal with transgressors of the code? How do you report complaints to the public? Lizel Jacobs, Legal & Compliance, Stryker South Africa: How do you deal with HCP requests that transgress the Code? Does your company educate HCPs on what is and isn’t allowed? How do you do that? If you are aware of an HCP or company that transgress the code, how do you manage this? Rob Millar, Chair, SAMED Code Committee What is different about the Medical Device Code of Ethical Marketing and Business Practice’s enforcement policies compared to others in the healthcare sector? How does SAMED enforce its Code? What are some of the queries received from members regarding the Code?

11h20 Networking break

11h40 12h00

The Medical Device Code of Ethical Marketing and Business Practice: What should Healthcare Professionals and Procurers know? by Rob Millar, Chair, SAMED Code Committee Please will you cover the following questions: Do you believe that the Medical Device Code of Ethical Marketing and Business Practice assists in procuring only quality Medical Devices? If so how? Has your entity / members embraced the code? Are there aspects of the Code that need changing and / or areas that have not been covered sufficiently? What more needs to be done in order to get all stakeholders on board and in support of the Code? Moderator: Rob Millar, Chair, SAMED Code Committee Panel Discussion: Tanushiya Mudely, Commercial Assurance Manager, Becton Dickinson – Africa: What are the key aspects and messages of the Code that Industry should be communicating to their customers? How can industry assist procurers in understanding the code? Roeland van Aelst, Regional Vice President: HCCO MD&D EMEA, Johnson & Johnson: What are the major differences between the MedTech Code and the SA Code? What has MedTech done to get procurers and HCPs on board? Where is MedTech with regard to prohibition of HCP sponsorship to third party arranged conferences? What is the value of industry codes aligning? How did you get the Medtech code endorsed by the European Union? What type of training and support does Medtech offer its members regarding code matters? Dr Sifiso Maseko, Acting CEO, Chris Hani Baragwaneth Hospital: Does Chris Hani Baragwaneth Hospital have any initiatives that ensure that there is no perversity in the relationship between its nurses and doctors working in your hospitals and the medical device industry? What more would you like the Code to cover? As a Procurer, what are your expectations of the Device Industry? ProfessorMartin Veller, Dean: Faculty of Health Sciences, University of Witwatersrand: What should Healthcare Professionals and Procurers know?

13h00 Lunch

14h00

PS 1 – Innovation Moderator: Anton Coetzee – Chair MDMSA CSIR’s Innovation Vision and Initiatives supporting Innovation by Dr Busi Vilakazi, Executive Director, CSIR: Please can you give us a brief outline of CSIR’s innovation vision and initiatives supporting innovation. Medical Technology Innovation in Israel, the Start Up Nation by Talor Sax, Founder and CEO, eHealth Ventures, Tel Aviv, Israel: Please will you cover how Israel transformed its medical device sector into what it is today? What key lessons can South Africa take away from the Israel story? Update on Global Health Innovation Accelerator by Dayne Morkel, Director, Global Health Innovation Accelerator: Please will you explain GHIA, its objectives and current projects.

PS 2 – Medical Devices in Spectrum Moderator: Avanthi Bester, Chairperson, SAMED / SALDA Africa Committee Software as a Medical Device by Saul Jankelow, Managing Director, Solumed Software Solutions: How is Software classified as a device? How does Software impact the healthcare industry and where you see software as a medical device in the future? How do you think that Software as a medical device will be regulated in the future? Regulating Combination and Borderline Medical Devices: How can South Africa learn from international Best Practice by Adrian Botha, Group One Sandown Village (invited) Please can you briefly cover how the MHRA deals with Combination Medical Devices? How are they classified? How are they regulated and governed? What can South Africa learn from this process? Industry Perspective on Regulating Combination and Borderline Medical Devices by Anele Vutha, Manager RAQA, Boston Scientific

15h00 Networking break

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PS 3 - Small Business and Start Ups: Funding mechanisms and government support available to small businesses and start ups Moderator: Marlon Burgess, SAMED Chair Dr Paul Johl, Senior Dealmaker: New Industries Business Unit, Industrial Development Corporation: Assisting Small Business in the Medical Device Industry- how the IDC can help and guide. We would like you to cover all current interventions the IDC has on offer for our small members highlighting any key specific incentives aimed at the health sector. Thakhani Makhuvha, CEO, Small Enterprise Finance Agency: SEFA’s offerings and current programmes for small businesses. We would like you to cover all current interventions the Small Enterprise Finance Agency has on offer for our small members highlighting any key specific incentives aimed at the health sector. Strini Perumal, Director: Private Sector R&D, Department of Science and Technology Department of Science and Technology’s Research and Development Tax Incentives : Please can you cover how the current incentives on offer for medical device companies looking to start research and development projects in South Africa.

PS 4 - Sustainable & Compliant Logistics in your Supply Chain by Jason Blackman, Director of Compliance, Customs and Regulatory Affairs, DHL Express Marketing and Promotional Practices in light of the new sections 18A and 18B of the Medicines Act by Altair Richards, Executive, Corporate commercial, ENS Africa Moderator: Avanthi Bester, Chairperson, SAMED / SALDA Africa Committee

16h20

Innovation and Analytics in the Healthcare Environment by Barry Childs, Joint CEO, Insight Actuaries & Consultants Moderator: Marlon Burgess, SAMED Chair

16h50 Closing remarks: Marlon Burgess, SAMED Chair

Please note the speakers and topics are subject to change.

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