Marco Gaudesi

• Dedicated and experienced pharmaceutical logistics consultant with a profound understanding of pharmaceutical supply chain, Good Storage and Distribution Practices (GSDP), cold chain management, Quality Management Systems (QMS), and regulatory compliance. Over a decade of comprehensive experience in end-to-end pharmaceutical quality assurance, including a proven track record in crafting global guidelines and Standard Operating Procedures (SOPs).
• Logistics Excellence and SOP Development:
• Specialized in optimizing pharmaceutical supply chains globally and developing comprehensive SOPs. My expertise extends to creating standardized processes that enhance operational efficiency and ensure compliance with international standards.
• RESPONSIBILITIES
• Quality Management Systems (QMS) and CAPA; A recognized expert in establishing and maintaining robust QMS frameworks globally, with a focus on crafting SOPs that drive continuous improvement. Proven ability to implement effective CAPAs programs with a standardized approach.
• Temperature Deviations and Compliance. Proficient in developing global guidelines for managing temperature deviations, ensuring adaptability across diverse regulatory landscapes while maintaining strict compliance.
• Regulatory Compliance Across Borders; Proven success in navigating diverse regulatory landscapes globally, aligning operations with the requirements of WHO, EU, and over 30 local regulatory bodies. Experience in crafting global guidelines ensures consistent compliance and quality assurance practices.
• Pharmaceutical humanitarian logistics. Solid experience in setting up pharmaceutical humanitarian supply chain and emergency immunization campaigns in limited resource settings.
• Responsible Person (RP) Expertise; As an RP for two years within a pharmaceutical wholesaler authorization context, ensured compliance with stringent regulatory requirements globally.

• Responsible Pharmacist (related to a WDA), accountable for the organization for ensuring compliance with the specific national and international regulation. Formal counterpart for the drug regulatory authorities.
• „ Focal point for the organization for the end-to-end management of cold chain and Good Storage and Distribution Practices (GSDP) and for temperature deviation management for medical products.
• „ Focal point for the global pharmaceutical regulatory compliance related to storage and distribution of pharmaceutical products within all the countries (30+) where the organization is present.
• „ Focal point for the establishment of organizational standards for cold chain procedures and equipment, encompassing temperature monitoring devices and isothermal packaging.

Main results

• „ pioneer of the first corporate GSDP guidelines
• „ main author of the first corporate cold chain guidelines
• „ co-author of the corporate manual: "developing a temperature-controlled medical storage facility".
• „ lead in creating an informatics help desk to effectively manage temperature deviations.
• „ architect of the pharmaceutical logistics setup in response to the Ukraine conflict crisis.

• Coordinating and conducting GDP audits in approximately 30 countries, ensuring compliance with global standards and guidelines. This involved collaborating with local teams, stakeholders, and regulatory bodies to assess and address any gaps in distribution practices. Spearheading internal audits in challenging contexts, overseeing: India, Niger, Cambodia, Mauritania, Afghanistan, Malawi, Mozambique, Zimbabwe, Haiti, Guinea, Pakistan, South Sudan, Kenya, Democratic Republic of Congo, Iraq, Kenya, Greece and Italy.
• „ Policy Development and Implementation: working collaboratively with local teams to develop and implement tailored GDP policies and procedures in alignment with national international standards.
• „ Training and Capacity Building: Designing and delivering comprehensive training programs to build the capacity of local staff in adhering to GDP guidelines. This included workshops, seminars, and ongoing support to ensure a sustainable culture of compliance.
• „ Emergency Response Logistics Planning: developing and implementing logistics plans for emergency operations, particularly in response to crisis situations. This included the timely and secure transportation of pharmaceuticals to areas affected by natural disasters, conflicts, or disease outbreaks.
• „ Mass Vaccination Campaigns: spearheading the logistics planning and execution of mass vaccination campaigns in collaboration with health authorities and international partners. Ensuring the timely delivery of vaccines while maintaining their integrity throughout the supply chain was a critical aspect of these campaigns. This activity included investigational products.
• „ Quality Control and Risk Mitigation: implementing rigorous quality control measures to safeguard the integrity of pharmaceuticals during storage and transportation. Proactively identifying and mitigating risks to ensure the availability of high-quality medical supplies during critical interventions.

Main results

• pioneered the establishment of the inaugural corporate supports for:

o GSDP and cold chain training

o self-inspection and CAPA follow-up

o controlled temperature, storage, and transport qualification

„ served as the pharmaceutical logistics focal point in the MSF international covid-19 taskforce.

• „coordinated all aspects of the first MSF Ebola vaccine clinical trials, including handling the vaccine under ultra-cold chain conditions.
• „designed the pharmaceutical logistics setup for two of the largest MSF emergency immunization operations, targeting one million individuals in DRC and 600k in Guinea
• „orchestrated the first organizational deployment of the oral cholera vaccine under the "controlled temperature chain," adhering to who requirements and collaborating with national regulatory authorities.
• „spearheaded the development of the first cooperative remote temperature control system for cold chain field stock, leading to its who prequalification and successful field implementation. This project led into significant organizations savings concerning temperature deviations.

Operating from Turkey, I played a pivotal role in ensuring the effective flow and distribution of medical supplies, with key responsibilities including:

-Medical Supply Management: Orchestrated the logistics and distribution of medical supplies to optimize healthcare delivery in challenging environments, ensuring timely and efficient support to MSF's interventions.

-Rational Drug Use Implementation: Implemented strategies to promote rational drug use, ensuring optimal and evidence-based utilization of pharmaceuticals in the field to enhance patient care.

-Medical Supply Local Procurement: Spearheaded local procurement initiatives, fostering partnerships with suppliers to secure vital medical resources and reduce dependency on external sources.

-Pharmacovigilance: Established and maintained pharmacovigilance systems to monitor and address the safety of medical products, contributing to the overall quality and safety of healthcare interventions.

-Planning of Poliomyelitis Vaccination Campaign: Led the strategic planning and execution of a poliomyelitis vaccination campaign, playing a crucial role in disease prevention and community health initiatives.

Medical Supply Management: Spearheading the strategic management of medical supplies, I streamline procurement processes, ensure the availability of essential medicines, and maintain robust inventory control systems to support MSF's critical medical interventions.

Pharmacy Set-Up: I contribute to the establishment and efficient functioning of pharmacies, ensuring they align with MSF standards. My focus extends beyond physical setups to encompass the development of standardized operating procedures that enhance overall pharmacy performance.

Strategic Input for New Project Openings: Collaborating closely with MSF teams, I provide strategic insights for the successful launch of new projects. My involvement spans the assessment of pharmaceutical needs, resource planning, and the development of comprehensive pharmacy strategies tailored to each unique context.

Rational Drug Use Implementation: Committed to promoting responsible and effective medication practices, I lead initiatives for the rational use of drugs. This involves developing protocols, conducting training sessions, and fostering a culture of evidence-based pharmaceutical decision-making.

Pharmacovigilance: Ensuring the safety and efficacy of pharmaceutical interventions, I oversee pharmacovigilance activities. My role involves monitoring and reporting adverse drug reactions, contributing to a continuous improvement cycle in patient care.

Planning of PCV Vaccination Campaign in Yida Refugee Camp: A testament to my project management skills, I orchestrated the successful planning and execution of the Pneumococcal Conjugate Vaccine (PCV) vaccination campaign in Yida Refugee Camp. This initiative underscored my ability to navigate logistical challenges and deliver critical healthcare interventions to vulnerable populations.

Medical Supply Management: Proficient in the strategic oversight of medical supply chains, ensuring timely and efficient availability of pharmaceuticals for mission success.

Pharmacy Set-up: Specialized in establishing and optimizing pharmacy infrastructures, creating organized and functional spaces that enhance the delivery of healthcare services in challenging environments.

Project Exploration (Explo): Proactive in conducting assessments for new projects, identifying key opportunities and challenges to inform decision-making processes and streamline project initiation.

Rational Drug Use Implementation: Advocate for and implement practices that ensure the rational use of medications, promoting optimal patient outcomes while minimizing risks and resource wastage.

Pharmacovigilance: Vigilant in monitoring and ensuring the safety of pharmaceuticals, implementing robust pharmacovigilance protocols to detect, assess, and prevent adverse effects.

Water and sanitation officer within the IFRC:

-Choucha Refugee Camp during the UNHCR and IFRC intervention following the onset of the Libyan conflict

-Port au prince post-earthquake and Cholera outbreak responses

Responsibilities:

Water Analysis and Treatment: Spearheaded comprehensive water analysis initiatives to ensure the provision of safe and clean water within the IFRC intervention area. Implemented strategic water treatment solutions to address challenges posed by the earthquake and Cholera outbreak, safeguarding the health and well-being of affected communities.

Hygiene Control: Developed and executed robust hygiene control programs to mitigate the risk of waterborne diseases. Collaborated with local communities to promote and implement effective hygiene practices, fostering a healthier living environment amidst challenging post-disaster conditions.

Temperature Mapping of Drug Storage Facilities: Played a crucial role in enhancing the efficacy of medical interventions by conducting temperature mapping of drug storage facilities. Implemented measures to optimize storage conditions, ensuring the integrity and potency of medical supplies in the aftermath of the earthquake and Cholera outbreak.