Michal Helbin Email & Phone Number

Toronto, On, Ca

Cambridge, Cambridgeshire, Gb

HRA Canada is an independent, not-for-profit accrediting body for human research. It accredits Canadian Human Research Protection Programs (HRPPs) through a voluntary, peer-driven program based on international standards for human research. The role of the Accreditation Council Member is to review accreditation applications, renewals and render decisions regarding accreditation.

Montreal, Quebec, Ca

HRSO is a Canadian, not-for-profit, standards development organization accredited by the Standards Council of Canada. HRSO develops National Standards of relevance to Canadians conducting, overseeing, and participating in human research. The role of Technical Committee Member is to develop national human research standards adhering or exceeding national standards to ensure harmonization, partnership and growth of this industry sector within Canada and internationally.

Toronto, Ontario, Ca

Established a proactive QMS to ensure the quality of drug substance and drug product, inspection readiness, patient safety, and data integrity. Managed internal and external audit programs, conducted audits of clinical investigator sites and contract manufacturing organizations for drug substance, drug product, and stability/release testing. Mastered the virtual audit process and inspection readiness during COVID lockdowns ensure continuous compliance of the clinical sites. Oversaw the Change Control process, ensuring effective handling of challenging incidents and modifications while maintaining compliance. Investigated internal and external Corrective and Preventive Action (CAPA) processes, from identification to tracking and closure. Formed the SOP committee and engaged the organization leaders to establish and adhere to QMS SOPs, ensuring compliance with regulatory requirements and best industry standards. Established, developed and monitored corporate KPIs including pre-established, smart quality tolerance limits to assess deliverable quality. Escalated issues when performance thresholds were not met. Established, maintained and delivered a comprehensive company training program related to GxP compliance.

Toronto, Ontario, Ca

Toronto, Ontario, Ca

Conducted thorough audits of GxP vendors, ensuring alignment with study protocols, corporate SOPs, regulatory standards, and GxP guidelines. Developed Regulatory Inspection Readiness Programs and conducted training for GxP and PV compliance, adhering to HC, FDA, EMA, MHRA, and TDA regulatory requirements. Ensured strict compliance with approved study protocols and Standard Operating Procedures (SOPs), meeting local and international regulatory standards and GxP guidelines. Established and maintained GxP quality systems, emphasizing effective reporting of deviations, Corrective and Preventive Actions (CAPA), investigations, incident management, and temporary deviations/excursions.

Lawrence Township, Nj, Us

QA expert in developing, implementing, and managing clinical programs in all phases (Phase I to Phase IV). Responsible for procedural document development, training, and implementation for clinical monitors and clinical site managers, ensuring clinical protocol compliance and patient safety. Conducted critical reviews of Clinical Protocols, Informed Consent Forms, Assent Forms, and other essential study documentation. Developed and delivered Standard Operating Document training sessions for PV (Drug Safety), Clinical, Regulatory, and Data Management divisions. Ensured Clinical Site readiness for Regulatory Inspections by FDA, EMA, MHRA, and other local European regulatory agencies. Planned and organized training sessions for on-site and remote staff, covering GxP topics such as Drug Safety, Study Documentation Compliance, IMPD Accountability, Return and Destruction, and Protocol Deviations and Exceptions Management.

Pharmaceutical Inspector and specialist in International Trade for Psychotropic Substances, Narcotic Drugs and Drug Precursors. Representative of MOH for Visegrád Group for the furthering of the European integration.Leveraged extensive knowledge as a Pharmaceutical Inspector and specialist in International Trade to ensure compliance with regulations related to Psychotropic Substances, Narcotic Drugs, and Drug Precursors. Provided strategic guidance as a consultant for the manufacturing and free movement of licit Drugs, Psychotropic Substances, and Drug Precursors in international controlled trade. Represented the Minister of Health in Drug Abuse Prevention Programs and Drug Abusers Rehabilitation Programs, advocating for public health and well-being. Coordinated the development of critical GxP modules for the “White EU Accession Book – Poland/EU. Managed Needs Assessment Missions arising from International Conventions on Narcotic Drugs and Psychotropic Substances, contributing to global efforts in drug abuse prevention. Prepared statements for the General Secretary of the United Nations Organization, UNDCP, and the International Control on Narcotic Drugs and Psychotropic Substances, demonstrating effective communication and diplomacy.

Голосіївський, Київ, Ua

Managed successfully research project to construct the database of all national drug stores.Assisted Cost Center Manager in development of research questionnaires to study Polish pharmaceutical market.