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Speakers
Director, Bob Tribe Consulting
Professional Background:
Over 40 years of experience in pharmaceutical regulatory affairs.
23 years as Head of GMP at the TGA Australia.
Former Chairman of PIC/S.
Global GMP Consultant assisting regulatory authorities worldwide in achieving PIC/S membership.
Key Achievements:
Assisted 15 GMP regulatory authorities obtain PIC/S membership over the past 18 years (the most recent was JFDA, Jordan which became a PIC/S member on 1 January 2026).
Currently assisting 6 GMP regulatory authorities prepare for either pre-accession or full accession to PIC/S.
Awards & Recognition:
US FDA Commissioner's Award (initiated ICH Q7A).
John Martin Memorial Award (RACI, Australia).
ISPE Joe Phillips Award for professional achievement.
Professional Background:
Over 40 years of experience in pharmaceutical regulatory affairs.
23 years as Head of GMP at the TGA Australia.
Former Chairman of PIC/S.
Global GMP Consultant assisting regulatory authorities worldwide in achieving PIC/S membership.
Key Achievements:
Assisted 15 GMP regulatory authorities obtain PIC/S membership over the past 18 years (the most recent was JFDA, Jordan which became a PIC/S member on 1 January 2026).
Currently assisting 6 GMP regulatory authorities prepare for either pre-accession or full accession to PIC/S.
Awards & Recognition:
US FDA Commissioner's Award (initiated ICH Q7A).
John Martin Memorial Award (RACI, Australia).
ISPE Joe Phillips Award for professional achievement.
Bob Tribe
Senior Regulatory Affairs Associate, Roche Holding AG
Professional Background:
A highly accomplished regulatory scientist with a decade of specialized experience in the evaluation, policy formulation, and registration of Biological Medicines. Founder and inaugural Chairperson of the African Blood Regulatory Forum (ABRF-TC) — a premier Continental Technical Working Group under the African Medicines Regulatory Harmonisation (AMRH) initiative. Spearheaded the historic unification of blood and blood product regulations across South Africa and the wider African continent.
This leadership has been pivotal in advising the African Medicines Agency (AMA) and AUDA-NEPAD, driving the creation of harmonized technical guidelines, innovative regulatory pathways, and reliance frameworks across Member States. A trusted voice on expert committees, bridging complex biological assessment with continental healthcare strategy to ensure equitable access to quality-assured, safe, and affordable blood products for all African citizens. Over the past 17 years, significant contributions have been made to the advancement of global health regulation through peer-reviewed publications and high-level international representation.
Key Publications & Research:
Published definitive frameworks on biosimilar registration and blood product implementation in the GaBI Journal and Research Square.
Authored a landmark 10-country sub-Saharan haemovigilance study.
Presentations & Speaking Engagements:
Featured speaker at the WHO's 18th International Conference of Drug Regulatory Authorities (ICDRA) in Dublin. Featured speaker at the 1st International Symposium on Streptococcus agalactiae Disease in Cape Town.
Professional Background:
A highly accomplished regulatory scientist with a decade of specialized experience in the evaluation, policy formulation, and registration of Biological Medicines. Founder and inaugural Chairperson of the African Blood Regulatory Forum (ABRF-TC) — a premier Continental Technical Working Group under the African Medicines Regulatory Harmonisation (AMRH) initiative. Spearheaded the historic unification of blood and blood product regulations across South Africa and the wider African continent.
This leadership has been pivotal in advising the African Medicines Agency (AMA) and AUDA-NEPAD, driving the creation of harmonized technical guidelines, innovative regulatory pathways, and reliance frameworks across Member States. A trusted voice on expert committees, bridging complex biological assessment with continental healthcare strategy to ensure equitable access to quality-assured, safe, and affordable blood products for all African citizens. Over the past 17 years, significant contributions have been made to the advancement of global health regulation through peer-reviewed publications and high-level international representation.
Key Publications & Research:
Published definitive frameworks on biosimilar registration and blood product implementation in the GaBI Journal and Research Square.
Authored a landmark 10-country sub-Saharan haemovigilance study.
Presentations & Speaking Engagements:
Featured speaker at the WHO's 18th International Conference of Drug Regulatory Authorities (ICDRA) in Dublin. Featured speaker at the 1st International Symposium on Streptococcus agalactiae Disease in Cape Town.
Khamusi Philip Mutoti
Senior Consultant to Regulatory Authorities (GMDP Inspectorates)
Professional Background:
About 40 years' experience in EOF (Medicines Agency of Greece), 5 years' in the Pharmaceutical Industry (Roche, Switzerland). Since 2018, a self-employed International Consultant to Regulatory Agencies to achieve PIC/S membership and WHO GBT ML3 to 4. Pharmaceutical Regulatory Expert with 37 years of experience, 12 of them as Head of GMDP at EOF, the Medicines Authority of Greece. Participated for more than 25 years in EU meetings in Brussels and EMA, involved in many EU Regulations preparation. Leadership in the implementation of a Quality System according to EU, PIC/S and ISO17020 in the Greek GMDP Inspectorate and the accession of EOF to PIC/S in 2002. Represented EOF/Greece and has been a member of the PIC/S Executive Bureau (Chair of Compliance Group, monitoring new applications at PIC/S). Involvement in several State Inspectorates' PIC/S and EU assessment Teams (US FDA, Romania, Austria, Cyprus, Iran, Uganda, Armenia, UNICEF) and at the EU-Japan MRA.
Performed GMP inspections with EDQM and WHO Prequalification Program in India and China and in missions as "Assistance to CFDA" project by WHO/Global Fund. Worked for the Industry at Roche, Switzerland in External Relations Europe.
Key Achievements & Experience:
Global GMP Consultant assisting regulatory authorities in obtaining PIC/S membership, including Armenia (2012), Turkey (2013), Jordan (2020-2025), China (2019, 2024), UAE (2026). Consultant for the successful assessment by WHO GBT on all functions of a regulatory authority.
Professional Background:
About 40 years' experience in EOF (Medicines Agency of Greece), 5 years' in the Pharmaceutical Industry (Roche, Switzerland). Since 2018, a self-employed International Consultant to Regulatory Agencies to achieve PIC/S membership and WHO GBT ML3 to 4. Pharmaceutical Regulatory Expert with 37 years of experience, 12 of them as Head of GMDP at EOF, the Medicines Authority of Greece. Participated for more than 25 years in EU meetings in Brussels and EMA, involved in many EU Regulations preparation. Leadership in the implementation of a Quality System according to EU, PIC/S and ISO17020 in the Greek GMDP Inspectorate and the accession of EOF to PIC/S in 2002. Represented EOF/Greece and has been a member of the PIC/S Executive Bureau (Chair of Compliance Group, monitoring new applications at PIC/S). Involvement in several State Inspectorates' PIC/S and EU assessment Teams (US FDA, Romania, Austria, Cyprus, Iran, Uganda, Armenia, UNICEF) and at the EU-Japan MRA.
Performed GMP inspections with EDQM and WHO Prequalification Program in India and China and in missions as "Assistance to CFDA" project by WHO/Global Fund. Worked for the Industry at Roche, Switzerland in External Relations Europe.
Key Achievements & Experience:
Global GMP Consultant assisting regulatory authorities in obtaining PIC/S membership, including Armenia (2012), Turkey (2013), Jordan (2020-2025), China (2019, 2024), UAE (2026). Consultant for the successful assessment by WHO GBT on all functions of a regulatory authority.
Dr. Vee (Vasiliki) Revithi
Founder & Managing Director, CONSILIUM LPG Consulting Services S.M.P.C.Chemist, TQM MBA. Senior Pharmaceutical Regulatory Expert.
Professional Background:
2022 – Present: Founder & Managing Director, CONSILIUM LPG Consulting Services S.M.P.C., Greece.Consulting services on GMP/GDP compliance, regulatory systems strengthening, quality management systems, and market surveillance of pharmaceutical enterprises.
International Consultant for pharmaceutical regulatory systems:
Jordan (JFDA / IFC – World Bank Group): PIC/S accession preparation, WHO GBT alignment, QMS development, SOPs, and inspector training.
Pakistan (DRAP / WHO): Strengthening market surveillance and control systems for substandard and falsified medical products.
UAE (Dubai Regulatory Authority): GMP/GDP compliance, inspection systems, and QMS strengthening.
2014 – 2021: Head of Production & Distribution Control Division (GMP/GDP Inspectorate), EOF Greece.
2011 – 2013: Head of Market Surveillance Section, EOF Greece.
Key Achievements & Experience:
More than 20 years of experience in GMP/GDP inspections, market surveillance, and pharmaceutical regulatory systems strengthening.
Successfully supported PIC/S accession and ISO/IEC 17020 accreditation of the EOF GMP/GDP Inspectorate.
Contributed to the EU–US FDA Mutual Recognition Assessment, confirming the equivalence of the Greek GMP inspection system.
Extensive experience supporting WHO, PIC/S, and EU regulatory alignment in Europe and the Middle East.
Expert in quality management systems (ISO 9001, ISO 17020, ISO 13485), risk-based post-marketing surveillance, and supply chain integrity.
Certified Trainer for Adults and External Assessor for Medical Devices Accreditation.
Official representative of the Greek Ministry of Health and EOF in several European and international regulatory bodies.
Professional Background:
2022 – Present: Founder & Managing Director, CONSILIUM LPG Consulting Services S.M.P.C., Greece.Consulting services on GMP/GDP compliance, regulatory systems strengthening, quality management systems, and market surveillance of pharmaceutical enterprises.
International Consultant for pharmaceutical regulatory systems:
Jordan (JFDA / IFC – World Bank Group): PIC/S accession preparation, WHO GBT alignment, QMS development, SOPs, and inspector training.
Pakistan (DRAP / WHO): Strengthening market surveillance and control systems for substandard and falsified medical products.
UAE (Dubai Regulatory Authority): GMP/GDP compliance, inspection systems, and QMS strengthening.
2014 – 2021: Head of Production & Distribution Control Division (GMP/GDP Inspectorate), EOF Greece.
2011 – 2013: Head of Market Surveillance Section, EOF Greece.
Key Achievements & Experience:
More than 20 years of experience in GMP/GDP inspections, market surveillance, and pharmaceutical regulatory systems strengthening.
Successfully supported PIC/S accession and ISO/IEC 17020 accreditation of the EOF GMP/GDP Inspectorate.
Contributed to the EU–US FDA Mutual Recognition Assessment, confirming the equivalence of the Greek GMP inspection system.
Extensive experience supporting WHO, PIC/S, and EU regulatory alignment in Europe and the Middle East.
Expert in quality management systems (ISO 9001, ISO 17020, ISO 13485), risk-based post-marketing surveillance, and supply chain integrity.
Certified Trainer for Adults and External Assessor for Medical Devices Accreditation.
Official representative of the Greek Ministry of Health and EOF in several European and international regulatory bodies.
Ms. Pantelia GKOURA
GMP Expert, Inspector with South African Health Products Regulatory Authority (SAHPRA)
Professional Background:
GMP Expert.
Inspector with South African Health Products Regulatory Authority (SAHPRA) responsible for conducting national and international inspections.
Chair of the GMP Technical Committee of African Medicines Regulatory Harmonization (AMRH).
Chair of the GMP Technical Committee focusing on Vaccine, Biological and API manufacture under the auspices of the African Medicines Regulatory Harmonization, which is transitioning to the African Medicines Agency.
Member of ZAZIBONA Inspection Team.
Member of WHO PQ inspection team.
Member of WHO RSS team.
Member of various workgroups e.g. Annex 1 Implementation team, Unique Facility Identifiers, Contamination and Cross Contamination in Shared facilities, Anti-Microbial Resistance and Waste Treatment.
Professional Background:
GMP Expert.
Inspector with South African Health Products Regulatory Authority (SAHPRA) responsible for conducting national and international inspections.
Chair of the GMP Technical Committee of African Medicines Regulatory Harmonization (AMRH).
Chair of the GMP Technical Committee focusing on Vaccine, Biological and API manufacture under the auspices of the African Medicines Regulatory Harmonization, which is transitioning to the African Medicines Agency.
Member of ZAZIBONA Inspection Team.
Member of WHO PQ inspection team.
Member of WHO RSS team.
Member of various workgroups e.g. Annex 1 Implementation team, Unique Facility Identifiers, Contamination and Cross Contamination in Shared facilities, Anti-Microbial Resistance and Waste Treatment.
Mr. Wayne Matheuw Müller
Manager of Biological Inspection Administration at Egyptian Drug Authority (EDA). Chair. of GMP subcommittee of vaccine at African Medicine Agency.
Professional Background:
Over 16 years of experience in pharmaceutical regulation and GMP inspections, with extensive expertise in biological products, vaccines, blood products, biosimilars, and plasma-related facilities.
Currently serving as Manager of the Biological Inspection Administration at the Egyptian Drug Authority since 2024.
Previously held several regulatory and leadership positions within EDA, including Chairman of the Technical Office (2022−2024).
Active contributor to WHO regulatory initiatives and African Medicines Regulatory Harmonization (AMRH) activities, including inspector training, quality systems development, and risk-based inspection programs.
Key Achievements & Experience:
Played a significant role in strengthening pharmaceutical regulatory systems at both national and international levels.
Contributed to the development and revision of regulations and guidelines related to radiopharmaceuticals, plasma apheresis centers, biosimilars, vaccines, and blood products in Egypt.
Internationally, collaborates with WHO and AMRH initiatives as a WHO GMP Advisor and focal point for biological inspections during WHO accreditation activities.
Serves as Chairperson of the Vaccine GMP Sub-Technical Committee at AMRH (AMA), leading initiatives for guideline harmonization, inspection capacity building, and regulatory strengthening across African countries.
Professional Background:
Over 16 years of experience in pharmaceutical regulation and GMP inspections, with extensive expertise in biological products, vaccines, blood products, biosimilars, and plasma-related facilities.
Currently serving as Manager of the Biological Inspection Administration at the Egyptian Drug Authority since 2024.
Previously held several regulatory and leadership positions within EDA, including Chairman of the Technical Office (2022−2024).
Active contributor to WHO regulatory initiatives and African Medicines Regulatory Harmonization (AMRH) activities, including inspector training, quality systems development, and risk-based inspection programs.
Key Achievements & Experience:
Played a significant role in strengthening pharmaceutical regulatory systems at both national and international levels.
Contributed to the development and revision of regulations and guidelines related to radiopharmaceuticals, plasma apheresis centers, biosimilars, vaccines, and blood products in Egypt.
Internationally, collaborates with WHO and AMRH initiatives as a WHO GMP Advisor and focal point for biological inspections during WHO accreditation activities.
Serves as Chairperson of the Vaccine GMP Sub-Technical Committee at AMRH (AMA), leading initiatives for guideline harmonization, inspection capacity building, and regulatory strengthening across African countries.
Dr. Heba Bahaa
Senior Vice President, BioEngine, China
Professional Background:
Has dedicated 25 years to the industrialization of protein drugs and viral biologics based on cell culture technology. In particular, he accumulates extensive experience in the efficient industrial production technology of biopharmaceuticals and viral vaccines, the medium and process development and large-scale manufacturing of the key raw materials—serum-free culture media, as well as the regulation of critical quality attributes of products.
As a lead, he has presided over multiple key projects—such as the National 863 Program, NSFC grants, and Shanghai Science and Technology Commission initiatives—he successfully addressed critical scale-up and engineering challenges, accelerating the industrialization of related bioproducts.
Key Achievements & Experience:
Contributed to regulatory infrastructure by serving as a principal drafter of China’s first two group quality standards for serum free media (T/SBIAORG 0002 2022 & T/SBIAORG 0003 2022), establishing the guides for cell culture medium quality
Professional Background:
Has dedicated 25 years to the industrialization of protein drugs and viral biologics based on cell culture technology. In particular, he accumulates extensive experience in the efficient industrial production technology of biopharmaceuticals and viral vaccines, the medium and process development and large-scale manufacturing of the key raw materials—serum-free culture media, as well as the regulation of critical quality attributes of products.
As a lead, he has presided over multiple key projects—such as the National 863 Program, NSFC grants, and Shanghai Science and Technology Commission initiatives—he successfully addressed critical scale-up and engineering challenges, accelerating the industrialization of related bioproducts.
Key Achievements & Experience:
Contributed to regulatory infrastructure by serving as a principal drafter of China’s first two group quality standards for serum free media (T/SBIAORG 0002 2022 & T/SBIAORG 0003 2022), establishing the guides for cell culture medium quality
Liang Zhao
Senior GMP Inspector/ Lead Inspector, South African Health Products Regulatory Authority (SAHPRA)
Professional Background:
Ms Mankeke F. Tlhoaele is an accomplished Senior GMP and Lead Inspector at the South African Health Products Regulatory Authority (SAHPRA), bringing 15 years of deep expertise in GxP regulatory oversight.
Throughout her career, she has led over 100 domestic and international inspections, covering a vast spectrum of complex manufacturing environments. Her technical expertise spans sterile and non-sterile facilities, including high-potency substances (hormones, cytotoxins), biomanufacturing (vaccines), radiopharmaceuticals, medicinal gases, and cannabis.
Key Achievements & Experience:
Beyond her national responsibilities, Ms. Tlhoaele has established herself as a prominent figure in international regulatory harmonization. She is appointed by the African Medicines Regulatory Harmonization (AMRH) as a GMP Inspector to participate in the Pilot of the Continental Listing of Medicinal Products. S
She is also an active member of the Southern African Development Community (SADC) GMP Quality Circle, contributing to regional quality assurance and regulatory collaboration.
Her leadership extends to the ZAZIBONA Initiative, where she serves as a Lead Inspector in collaborative medicines registration inspections across SADC member states. In addition, she has supported global quality standards through her role as a Seasonal GMP Inspector with the World Health Organization (WHO) Prequalification Inspection Service contributing to the assurance of safe, effective, and high-quality medicines worldwide.
Professional Background:
Ms Mankeke F. Tlhoaele is an accomplished Senior GMP and Lead Inspector at the South African Health Products Regulatory Authority (SAHPRA), bringing 15 years of deep expertise in GxP regulatory oversight.
Throughout her career, she has led over 100 domestic and international inspections, covering a vast spectrum of complex manufacturing environments. Her technical expertise spans sterile and non-sterile facilities, including high-potency substances (hormones, cytotoxins), biomanufacturing (vaccines), radiopharmaceuticals, medicinal gases, and cannabis.
Key Achievements & Experience:
Beyond her national responsibilities, Ms. Tlhoaele has established herself as a prominent figure in international regulatory harmonization. She is appointed by the African Medicines Regulatory Harmonization (AMRH) as a GMP Inspector to participate in the Pilot of the Continental Listing of Medicinal Products. S
She is also an active member of the Southern African Development Community (SADC) GMP Quality Circle, contributing to regional quality assurance and regulatory collaboration.
Her leadership extends to the ZAZIBONA Initiative, where she serves as a Lead Inspector in collaborative medicines registration inspections across SADC member states. In addition, she has supported global quality standards through her role as a Seasonal GMP Inspector with the World Health Organization (WHO) Prequalification Inspection Service contributing to the assurance of safe, effective, and high-quality medicines worldwide.
Mankeke F Tlhoaele
Senior Vice President, Strategic Compliance Consulting, Parexel
Professional Background:
Mark Birse has over 30 years of pharmaceutical industry experience, including 17 years at the UK Regulator (MHRA) and 25 years of performing both GMP/GDP audits and regulatory inspections of human and veterinary medicines.
He is a former Head of the MHRA GXP Inspectorate and Deputy Director, Inspection, Enforcement and Standards
Key Achievements & Experience:
Mark led the creation of the risk-based inspection and compliance management principles at MHRA and PIC/S GMP Reliance Procedure.
He also headed up MHRA Digital Health team 2018-2019, including x-Government AI meetings.
He is a former PIC/S Executive Bureau member and PIC/S lead assessor (assessing various agencies including FDA and ANVISA).
He has had a Qualified Person eligibility since 2003 and IRCA Principal Auditor PQMS - GMP Scheme.
Professional Background:
Mark Birse has over 30 years of pharmaceutical industry experience, including 17 years at the UK Regulator (MHRA) and 25 years of performing both GMP/GDP audits and regulatory inspections of human and veterinary medicines.
He is a former Head of the MHRA GXP Inspectorate and Deputy Director, Inspection, Enforcement and Standards
Key Achievements & Experience:
Mark led the creation of the risk-based inspection and compliance management principles at MHRA and PIC/S GMP Reliance Procedure.
He also headed up MHRA Digital Health team 2018-2019, including x-Government AI meetings.
He is a former PIC/S Executive Bureau member and PIC/S lead assessor (assessing various agencies including FDA and ANVISA).
He has had a Qualified Person eligibility since 2003 and IRCA Principal Auditor PQMS - GMP Scheme.
Mark Birse
