DR. NOHA EL-HARIRI

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Dr. Noha El Hariri is the general manager of the general medical device registration administration-Egyptian drug authority (EDA).

She had Bachelor of Clinical Pharmacy year 2003 with excellent grade with honor.
She had MBA (Master of Business Administration in health economics) with grade excellent with honor.

She worked in the central administration for pharmaceutical affairs since 2004 as inspector
In 2011 she left the inspection department and joined the medical device department since 2011.

In 2013 she became head of variation department in medical devices unit.
In 2020 she became general manager of registration department.

 

MR. MARK BANFIELD

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MS. SARAH COHEN

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  • Cohen has over 25 years’ experience in laboratory testing and research, specializing in IVDs and clinical trials.

Executive Officer – SALDA – since August 2019

  • Liaising with members and other stakeholders as needed relating to the MedTech Industry with emphasis on IVDs

Offers support in laboratory management, accreditation and oversight of  clinical trial laboratories

Monitoring , assessing and auditing of clinical trial and laboratory  processes

Training, lecturing, coaching and mentoring of clinical trial staff / pharmaceutical sciences students

 

She has previously held senior positions in the fields of laboratory medicine and clinical trials

Education

She obtained her Bachelor degree in Laboratory Management (Pretoria), Masters in Operations

Management (Johannesburg) and MBA (Australia)

 

MS. MICHELLE BULLIARD

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Ms. Bulliard has over 25 years’ experience in real-world evidence studies, patient registries, safety surveillance programs, and other specialized real-world programs. She has an extensive global portfolio, specializing in medical device & diagnostics studies.

Ms. Bulliard works with medtech companies around the world to design & deliver solutions that translate evolving methodological real-world research standards and real-world data generation methods into feasible operational delivery strategies to meet the needs of regulators, payers, providers & patients.

A subject matter expert in RWE medical device, diagnostic and digital health studies with a robust knowledge of the current and evolving clinical, regulatory, scientific and commercial medtech landscape, she seeks to generate product value by leveraging the most effective, innovative and compelling strategies within the marketplace.

Ms. Bulliard is a member of IQVIA’s MedTech Center of Excellence representing the domain of real-world evidence.

She has previously held senior positions in the field of post market safety and real-world research in medical device and biotech companies.

Education

She has obtained her Bachelor of Science in Nursing, BScN, RN, from Dr Steevens Hospital  / Trinity College Dublin Ireland, with a P. Grad. Dip in Critical Care ICU Dublin, Ireland and Lausanne, Switzerland.

 

MR. ROB VAN DEN BERGH

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Rob is Regional Director, sub-Saharan Africa at Oximio, which includes operations in South Africa and the newly opened facility in Kenya. Both are licensed pharmaceutical distribution warehouses, specialising in global clinical trial supply procurement, comparator sourcing, repackaging, storage and distribution.

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Oximio, previously known as the SMO Group, has a rapidly expanding GxP storage and services network focused on Eastern Europe, the Middle East and Africa. Along with the two facilities in serving the sub-Saharan region, Oximio also operates through a partner depot in Egypt in Africa.

 

Oximio in Kenya runs a Customs Bonded depot, and serves as a gateway to East, Central and West Africa. This enables cost-effective solutions and quick turnaround times in the region and substantially improves patient access to medicine, particularly in difficult to reach areas and marginalised populations.

 

Rob’s background

Rob entered the Clinical Supply Chain market in 2002 and continues to build and maintain mutually beneficial relationships with local and international sponsors, manufacturers, and other key stakeholders including regulators and Research Organisations.

 

As a leader, team player and brand ambassador, and through Oximio clients, Rob is focussed on attracting a wider range of research into sub-Saharan Africa.

 

MR. NEVILLE MAYHEW

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Neville is a Global Project Manager, Import Export Specialist, Africa Region at Oximio, responsibilities include the coordination and completion of all projects on time, within budget and to the client requirements. This involves overseeing all aspects of projects, monitoring and summarising progress of project and ensuring the reports are prepared key stakeholders of the business regarding status of project.

Oximio, previously known as the SMO Group, has a rapidly expanding GxP storage and services network focused on Eastern Europe, the Middle East and Africa. Along with the two facilities in serving the sub-Saharan region, Oximio also operates through a partner depot in Egypt in Africa.

 

Oximio in Kenya runs a Customs Bonded depot, and serves as a gateway to East, Central and West Africa. This enables cost-effective solutions and quick turnaround times in the region and substantially improves patient access to medicine, particularly in difficult to reach areas and marginalised populations.

 

Neville’s background

Neville entered the Clinical Supply Chain market in 2014 working for various carrier in the clinical trial sector and continues to build and maintain mutually beneficial relationships with local and international sponsors, manufacturers, and other key stakeholders including regulators and Research Organisations.

MS. NADIA ISSAD

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SIMONE RUDOLPH-SHORTT

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An Industrial Pharmacist of 30 years. Started her career at Adcock Ingram (pre – Sterling Winthrop) in production of Panado tablets and Syrup before moving to Smith & Nephew in 1992, which became BSNmedical (2001), National Bio-products (20004) as Pharmacist Plant Manager (ampoules / Vials ) followed by own Consulting business 2005.

 

At Smith & Nephew, Introduced to medical devices such as burns creams, wound dressings, bandages and plasters and the new quality management system, at the time, ISO9001 and moving to ISO 13485 in 2000.

 

Worked in Production, Quality Assurance, Regulatory affairs, Validation and Laboratory Management of a chemistry, microbiology and textile laboratory.

 

In 2005, the consultancy business started providing;

  • Consultation on quality management systems (ISO9001/22001/13495) regulatory requirements, product licensing, company registration for medicines and medical devices
  • Training in-house or public venue on the development, implementation and maintenance of a quality managements system (ISO13485), good manufacturing practices and internal auditing for conformity assessment certification and
  • Documentation requirements for risk assessment (ISO 14971), procedures, clinical evaluation, technical file and declaration of conformity

 

A member of PSSA, SAAPHI, SAHFE, SAMED , MDPG (Chairperson 2019) MDMSA (chairperson 2021),  and is a committee member of the SAMED Regulatory and Procurement committees and the SABS Technical committees for textiles and medical devices

MS. SUSAN LIN

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She is a qualified pharmacist with a Bachelor of Pharmacy from Rhodes University and has worked extensively in the healthcare industry.  She has spent the majority of her career in health risk management / managed care.

Susan began her career serving as a dispensing pharmacist in public as well as private sector but later progressed to the Managed Care industry where she managed several portfolios. Her positions included the Executive Manager: Medicines Risk & Electronic Benefit Management and Specialist: Business Modelling & Coordination.

Her notable achievements was on the public and private partnership initiatives in enabling access to care. She consulted for a number of segments within the healthcare industry whereby she facilitated the streamlining of access to primary healthcare and development of technologies to support maternal and child care.

Currently, Susan is heading up the Health Policy Unit where she is responsible for the development of strategies for enabling access to pharmaceutical, technological and medical procedures. One of her ambitions is finding sustainable solutions in building reimbursement models to facilitate the funding of specialised medicines in South Africa.

MS. SALMA SALIM

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Salma Salim is an experienced Regulatory Affairs expert specialized in medical devices. She has worked for multiple medical devices companies for more than 12 years. During her career Salma has covered all the regulatory aspects in several regions: Europe, USA, Japan, China, Middle East and Africa. Salma is graduated from the Pharmaceutical School of Châtenay-Malabry (Paris XI – France) where she had her master’s degree in “Quality and Health products”.

 

In her current role as Senior Regulatory Affairs Program Manager at GE Healthcare, Salma is responsible for building RA strategy in Africa and covering all the regulatory aspects (Products registrations, Matereovigilance, Regulatory Intelligence…). She is also continuously interacting with the ministry of health representatives in the regulated countries within the region.