Be part of the future of Life Sciences
The event for Quality and Supply Chain professionals
Sync Space
is back!
After a successful first edition with 7 sessions and workshops led by international speakers and attended by 30+ renowned companies like Insud Pharma, Brenntag, or Almirall, the annual gathering for the Life Sciences ecosystem is back!
Michael C. Rogers
With over 30 years of leadership at the U.S. FDA, Michael C. Rogers most recently served as Associate Commissioner for Inspections and Investigations, overseeing the agency’s global inspectorate of more than 4,000 professionals. His responsibilities spanned criminal investigations, import operations, and emergency response. He played a key role in leading the FDA’s largest reorganization and has testified before Congress on critical public health issues.
Earlier in his career, Michael directed food safety operations across 1,100+ staff and served as Regional Director for Latin America, managing FDA offices in Mexico, Costa Rica, and Chile, and leading regulatory efforts across 44 countries. He began his career as a field investigator conducting domestic and foreign inspections in a variety of program areas.
Asena Serbezova
A GxP consultant and ISO 9001 & GxPs lead auditor with over 28 years of experience, she specializes in quality assurance, regulatory affairs, and pharmacovigilance for stakeholders in human medicines.
As a professor at the Medical University-Sofia, Asena teaches drug legislation and health policy.
Key achievements include serving as Executive Director of the Bulgarian Drug Agency, a member of the National Committee of Pricing and Reimbursement of Medicines, and contributing to drug legislation in Bulgaria. She has also been part of the European Medicines Agency's Management Board and has published works on pharmacoeconomics and pharmaceutical biotechnology.
Ebru Mert
Ebru Mert is the founder of Sisthema-EGM, a consultancy firm specializing in validation, qualification, regulatory compliance, and training. A Chemistry graduate from Boğaziçi University, she has built a career in the pharmaceutical and packaging industries with a focus on quality management.
Since 2007, she has provided expert consultancy on GMP compliance and quality systems, and since 2012, has conducted GxP audits worldwide. Her expertise includes process and cleaning validation, equipment qualification, quality risk management, and global regulatory compliance. Known for her hands-on approach, Ebru is a trusted advisor in pharmaceutical quality.
Juan Torres
Dr. Juan Torres is a NIIMBL Senior Fellow and President of Ingenuitas, a non-profit organization dedicated to advancing innovative health solutions for underserved communities and STEM education. With over 30 years of leadership experience in the biotechnology and pharmaceutical sectors, he specializes in quality systems innovation, biopharmaceutical development, and regulatory compliance. Previously, Juan served as Chief Quality Officer at Biogen for almost two decades. He has also held Quality executive positions at Bayer and J&J. He now leads Futurum Biosciences, a consultancy focused on enhancing biotech quality processes. Known for his integrity, global perspective, and commitment to mentorship, Juan continues to make significant contributions to the advancement of biotechnology. He holds PhD degrees in Biochemistry and Toxicology, as well as postdoctoral experience in Chemical Engineering from North Carolina State University.
Zuzana Horáková
Zuzana Horáková is Associate Director of Quality & Compliance at TAPI Czech Industries, with over 15 years of experience in the pharmaceutical industry. She specializes in QMS improvement, GMP compliance, site inspection readiness, and quality auditing.
Formerly a Global Quality Auditor and QA Inspector, Zuzana supports complex, customer-driven projects with a focus on data integrity and regulatory alignment. A strong communicator and advocate for women in leadership, she also contributes as a speaker and consultant. She holds a Master’s in Food Science and Biotechnology and is certified as a Qualified Person and in Women in Leadership & AI.
John Athayde
John brings over 40 years of extensive experience in the pharmaceutical sector, with a distinguished career at GSK as Vice President of Supplier Quality for the Asia-Pacific region.
Overseeing the quality management of approximately 1,400 vendors, John has demonstrated exceptional leadership in manufacturing, R&D, quality assurance, and auditing.
His expertise spans auditing more than 200 suppliers across Japan, China, India, and Indonesia, and he has played a pivotal role in training and certifying auditors in these regions. John's global auditing experience includes GSK sites in the UK, Belgium, India, Pakistan, Bangladesh, Sri Lanka, Vietnam, and Singapore.
A Qualified Trainer, Certified Auditor, and Green Belt in Lean Sigma, John is recognized for his strategic oversight and commitment to excellence in pharmaceutical quality management.
Emmanuel Klem-Robin
Emmanuel is a Quality and Compliance Consultant and Auditor with 25 years of experience in the pharmaceutical and medical device industries. A former analytical chemist and QC lab head, he also teaches Quality Management in Health Industries at Montpellier University.
He supports companies in improving QMS through risk management and QbD coaching. With extensive FDA experience from his time in Canada, he has prepared numerous sites for FDA PAIs. He also works with ISO-based QMS for medical devices and serves as Quality Director for a biotech start-up focused on clinical studies and product development.
Urbici Cardona
Born in Barcelona on latest 60s, my background is BSc Honours Degree in Chemical Engineering (Institut Químic de Sarrià | Spain) and Bachelor of Chemistry (Universidad Ramón Llull | Spain). Several complementary studies have been completed like Master’s Total Quality Management (TQM) (Fundació Politécnica Catalunya, UPC | Spain) and Executive Education Program “Dirección de Empresas de Servicios” (ESADE | Spain).
During the last 27 years I have been working as Pharmaceutical Consultant & GXP Auditor. First, I have been working for almost 20 years in a Consultancy Company also acting as Quality Manager responsible for the Quality Management System in place certified according to ISO 17001. The last 7 years I have been working as freelance Consultant and Auditor under the brand Strategics Qualitas Solutions.
As a Pharmaceutical Consultant involved in assessment of GxP compliance and involved in validation and qualification projects (utilities, processes, computerized systems, etc). As a GxP auditor, I have been involved in more than 330 audits to all types of pharmaceutical suppliers/manufacturers worldwide including GMP and GDP audits.
In addition, I have been responsible for the Medical Device Unit in a Pharmaceutical Consultancy company for 5 years.
Michael C. Rogers
With over 30 years of leadership at the U.S. FDA, Michael C. Rogers most recently served as Associate Commissioner for Inspections and Investigations, overseeing the agency’s global inspectorate of more than 4,000 professionals. His responsibilities spanned criminal investigations, import operations, and emergency response. He played a key role in leading the FDA’s largest reorganization and has testified before Congress on critical public health issues.
Earlier in his career, Michael directed food safety operations across 1,100+ staff and served as Regional Director for Latin America, managing FDA offices in Mexico, Costa Rica, and Chile, and leading regulatory efforts across 44 countries. He began his career as a field investigator conducting domestic and foreign inspections in a variety of program areas.
Asena Serbezova
A GxP consultant and ISO 9001 & GxPs lead auditor with over 28 years of experience, she specializes in quality assurance, regulatory affairs, and pharmacovigilance for stakeholders in human medicines.
As a professor at the Medical University-Sofia, Asena teaches drug legislation and health policy.
Key achievements include serving as Executive Director of the Bulgarian Drug Agency, a member of the National Committee of Pricing and Reimbursement of Medicines, and contributing to drug legislation in Bulgaria. She has also been part of the European Medicines Agency's Management Board and has published works on pharmacoeconomics and pharmaceutical biotechnology.
Ebru Mert
Ebru Mert is the founder of Sisthema-EGM, a consultancy firm specializing in validation, qualification, regulatory compliance, and training. A Chemistry graduate from Boğaziçi University, she has built a career in the pharmaceutical and packaging industries with a focus on quality management.
Since 2007, she has provided expert consultancy on GMP compliance and quality systems, and since 2012, has conducted GxP audits worldwide. Her expertise includes process and cleaning validation, equipment qualification, quality risk management, and global regulatory compliance. Known for her hands-on approach, Ebru is a trusted advisor in pharmaceutical quality.
Juan Torres
Dr. Juan Torres is a NIIMBL Senior Fellow and President of Ingenuitas, a non-profit organization dedicated to advancing innovative health solutions for underserved communities and STEM education. With over 30 years of leadership experience in the biotechnology and pharmaceutical sectors, he specializes in quality systems innovation, biopharmaceutical development, and regulatory compliance. Previously, Juan served as Chief Quality Officer at Biogen for almost two decades. He has also held Quality executive positions at Bayer and J&J. He now leads Futurum Biosciences, a consultancy focused on enhancing biotech quality processes. Known for his integrity, global perspective, and commitment to mentorship, Juan continues to make significant contributions to the advancement of biotechnology. He holds PhD degrees in Biochemistry and Toxicology, as well as postdoctoral experience in Chemical Engineering from North Carolina State University.
Zuzana Horáková
Zuzana Horáková is Associate Director of Quality & Compliance at TAPI Czech Industries, with over 15 years of experience in the pharmaceutical industry. She specializes in QMS improvement, GMP compliance, site inspection readiness, and quality auditing.
Formerly a Global Quality Auditor and QA Inspector, Zuzana supports complex, customer-driven projects with a focus on data integrity and regulatory alignment. A strong communicator and advocate for women in leadership, she also contributes as a speaker and consultant. She holds a Master’s in Food Science and Biotechnology and is certified as a Qualified Person and in Women in Leadership & AI.
John Athayde
John brings over 40 years of extensive experience in the pharmaceutical sector, with a distinguished career at GSK as Vice President of Supplier Quality for the Asia-Pacific region.
Overseeing the quality management of approximately 1,400 vendors, John has demonstrated exceptional leadership in manufacturing, R&D, quality assurance, and auditing.
His expertise spans auditing more than 200 suppliers across Japan, China, India, and Indonesia, and he has played a pivotal role in training and certifying auditors in these regions. John's global auditing experience includes GSK sites in the UK, Belgium, India, Pakistan, Bangladesh, Sri Lanka, Vietnam, and Singapore.
A Qualified Trainer, Certified Auditor, and Green Belt in Lean Sigma, John is recognized for his strategic oversight and commitment to excellence in pharmaceutical quality management.
Emmanuel Klem-Robin
Emmanuel is a Quality and Compliance Consultant and Auditor with 25 years of experience in the pharmaceutical and medical device industries. A former analytical chemist and QC lab head, he also teaches Quality Management in Health Industries at Montpellier University.
He supports companies in improving QMS through risk management and QbD coaching. With extensive FDA experience from his time in Canada, he has prepared numerous sites for FDA PAIs. He also works with ISO-based QMS for medical devices and serves as Quality Director for a biotech start-up focused on clinical studies and product development.
Urbici Cardona
Born in Barcelona on latest 60s, my background is BSc Honours Degree in Chemical Engineering (Institut Químic de Sarrià | Spain) and Bachelor of Chemistry (Universidad Ramón Llull | Spain). Several complementary studies have been completed like Master’s Total Quality Management (TQM) (Fundació Politécnica Catalunya, UPC | Spain) and Executive Education Program “Dirección de Empresas de Servicios” (ESADE | Spain).
During the last 27 years I have been working as Pharmaceutical Consultant & GXP Auditor. First, I have been working for almost 20 years in a Consultancy Company also acting as Quality Manager responsible for the Quality Management System in place certified according to ISO 17001. The last 7 years I have been working as freelance Consultant and Auditor under the brand Strategics Qualitas Solutions.
As a Pharmaceutical Consultant involved in assessment of GxP compliance and involved in validation and qualification projects (utilities, processes, computerized systems, etc). As a GxP auditor, I have been involved in more than 330 audits to all types of pharmaceutical suppliers/manufacturers worldwide including GMP and GDP audits.
In addition, I have been responsible for the Medical Device Unit in a Pharmaceutical Consultancy company for 5 years.
Striking the right balance between tailored and comprehensive audits is key to effective quality management. This session explores how organizations can align focused, risk-based audits with broad oversight strategies to enhance compliance and performance. Through case studies and a structured SWOT analysis, we’ll examine the strengths and limitations of each approach, and how to combine them for optimal impact.
Quality oversight covers the entire spectrum of biomanufacturing activities, yet today it is lagging behind technological advancements. In this talk, Juan Torres will explore a future vision of Quality oversight, based on automated data collection, continuous data monitoring at every step of biomanufacturing, predictive analytics and the latest technologies. He will offer examples of early adopters, as well as a roadmap to innovation that takes into account concrete challenges and opportunities.
Managing pharmaceutical development within ICH Q8 guidelines is complex, especially with CDMO transfers and data loss. This session explores how an agile, development-specific QMS can support knowledge retention, regulatory compliance, and GMP batch readiness. Learn practical tools to streamline development while maintaining control across shifting teams and evolving projects.
In this interactive workshop, participants will assess a real supplier case through audit details and team-based analysis. After breaking into groups to evaluate different focus areas (QMS, Facilities, Validation), findings will be shared and discussed to reach a joint compliance decision. The session wraps up by introducing strategic criteria like the Trust Rate to enrich supplier evaluation beyond standard audits.
Step into a high-stakes supplier qualification challenge designed for pharma professionals. This interactive workshop blends real-world case studies with a hands-on escape room game to sharpen your risk-based decision-making. Collaborate, compete, and learn how to proactively manage supplier risks under regulatory pressure before the next crisis hits.
Explore how trust transforms suppliers into long-term partners. This session will unpack real-world examples, practical tools, and key pillars that strengthen collaboration. Learn how to build resilient partnerships, avoid costly breakdowns, and navigate the risks of over-dependency with strategies grounded in experience and open dialogue.
Explore how AI and digitalization are transforming compliance in pharma, from predictive audits to real-time quality monitoring. This session highlights current innovations, adoption gaps, and the untapped potential of automation across labs, manufacturing, and post-market activities. Discover what’s possible now, and what’s next by 2050.
