AAPS leading industry faculty utilizes years of global expertise to bring training sessions to life with engaging instructional methods and real world examples. We always match faculty members that suit your organization’s culture.
Mr. Ehsan Adiban
Ehsan Adiban is a Registered Nurse at Sunnybrook Hospital, Toronto, Ontario, Canada. He has 21 years nursing experience in different fields such as critical care, coronary care, nursing education and management in addition to European and American resuscitation councils as an instructor. He currently consults clients in the nursing field and CRNE preparation courses; assisting them with assessment and placement for the CRNE and specialty courses and is an instructor at AAPS.
Ehsan works in the Cardiac Cath Lab at Sunnybrook Health Science Center. He has gained significant insights to the regulatory requirements and expectations of the college of nurses of Ontario to develop different courses for health care professionals specially nurses, either locally or internationally trained, to be assessed and placed to be successful in their licensing exam and future careers. He has an excellent understanding of the regulatory requirements for nursing development; the CRNE requirements expected for nurses and have assisted former applicants numerous times in being successful in their careers and exams.
Prior to this, Ehsan worked as a clinical nurse, nurse manager and educator at American standard organizations. During his 20 years in nursing field he led many projects in emergency departments, critical care units and many programs for nurses in staff development department. He was recognized as the best instructor and received an award for his excellent service in 2010 as emergency care manager in addition to JCI accreditation in American standard system hospitals.
Ehsan also has a solid background in life saving courses such as ACLS, Disaster Management courses, and customer care courses in healthcare field. He is a BSN, MBA, TRI, ERI and ARI graduate from internationally recognized organizations and holds American and Canadian Nursing license.
Dr. Domenic Cianflone, BCom, MBA, PhD, CMA
President and Chief Executive Officer
Synergy Management Consulting Inc.,
Dr. Cianflone is the founder of Synergy Management Consulting Inc., a boutique firm. His industry experience covers distribution, professional services, pharmaceutical, and staffing. His areas of expertise include financial management, strategic planning, logistics operations, balanced scorecards, activity-based management, leadership training, corporate governance, and recruitment. Throughout his career, he has directed numerous projects in strategy, financial management, and human resource management.
Dr. Cianflone is a lecturer at the Schulich School of Business at York University, the University of Toronto Mississauga, Wilfrid Laurier University, and Ryerson University. In addition, he is a PhD advisor with Rushmore University and has held teaching appointments at Humber College. His teaching specialisations include management accounting, business strategy, financial analysis and reporting, and finance for non-financial managers. He is a published author and lectures in both undergraduate and graduate programmes. In addition, he has been a speaker on ethical leadership and recruitment best practices.
Dr. Cianflone holds a Bachelor of Commerce degree from Ryerson University, a Master of Business Administration degree from Heriot-Watt University (Edinburgh, UK), and a Doctorate from Rushmore University, successfully defending a thesis in the areas of strategic leadership and management accounting. Furthermore, he holds the prestigious Certified Management Accountant (CMA) designation and is also enrolled in Canadian Institute of Traffic and Transportation (CITT) program of professional studies.
Dr. Cianflone is a member of the CMA Ontario Board of Governors, is a member of the CMA Ontario District Advisory Committee, and is a level four Hockey Canada referee. Dr. Cianflone currently teaches Finance for Non-Financial Managers at AAPS
Mr. Danny Dean, MBA
Mr. Dean holds a Master’s degree in Business Administration from the Schulich School of Business at York University [Toronto], with a focus on strategic marketing and strategic business management.
In addition to his academic credentials, Mr. Dean has over 35 years of experience working in the Canadian pharmaceutical industry, on both the agency and client side, and has held a number of management positions in sales & marketing.
Mr. Dean is Managing Director of Ansera Business Solutions Inc., a specialized consulting firm that focuses on pharmaceutical sales and marketing excellence, and on helping its clients to achieve breakthrough sales results.
Dr. Sahba Eftekhary Shirkoohy, MD, MPH, MHA, CHE, PMP, PhD Candidate
Dr. Sahba Eftekhary has an extensive background in health care administration, research, performance management and measurement, healthcare quality, program planning and evaluation. She has extensive work experience at various levels of the healthcare industry, including the Ministry of Health and Long-Term Care, the hospital sector, as well as collaboration with international agencies, including the UN and WHO. She has provided strategic direction and coordination to several nationally/internationally-sponsored health services projects. She has received grants from peer-reviewed federal and provincial research funding agencies and published research papers related to many aspects of the healthcare system.
Currently, she is a Senior Project Manager at the University Health Network. In addition to being a physician, Sahba holds a Master of Public Health (MPH), as well as a Master of Health Administration (MHA) from the University of British Columbia. She is a PhD Candidate at the University of Toronto in Health Administration, with a focus on Health Services Outcomes and Evaluation and healthcare financing options.
Ms. Anita Ferrari
Director of Quality Systems
Anita Ferrari has over 20 years experience in the pharmaceutical industry and started as a quality control chemist at Smith Kline Beecham. Over the years she has worked in many areas throughout the industry and her experience includes areas such as: QC chemist, microbiology, validation specialist, auditor, manufacturing controls, documentation, Quality Assurance, distribution and CAPA investigations.
She is currently the director of Quality System and Pancap Inc. and is responsible for the maintaining of the overall quality for the contract manufacturing facility.
Anita graduated with a Bachelor of Science in Applied Chemistry and Biology from Ryerson.
Mr. Walter Hahn
Walter is the instructor, lecturer and laboratory supervisor/manager for most of the Pharma laboratory courses at AAPS. He received his formal training as a chemist at the University of Waterloo, where he received an Honors Bachelor of Science in Chemistry in 1986. He majored in organic chemistry and had his name on two publications for his work in synthetic chemistry.
From his first position in Quality Control (1986) as an analyst, to his most recent position with Patheon as a Raw Material supervisor, Walter has acquired over 20 years experience in the Pharmaceutical industry, with 12 of those as a QC supervisor in Shelf Life Stability, Finished Products and Raw Materials. His experience ranges from method development and validation for HPLC, documentation auditing and GMP trainer, to technical writing, lecturing and laboratory management. He has worked for several different companies including generic pharmaceutical manufacturers, innovators, contract laboratories and contract manufacturers.
Ms. Tania John, B.Sc., M.Sc.
Regulatory Affairs Specialist, Nutrition & Nutraceutical Research Division
Nutrasource Diagnostics Inc.
Tania John has worked for several years in the Natural Health Product and Food industry, specializing in Regulatory Affairs and Quality Assurance. She holds a Bachelor of Science in Nutrition & Nutraceutical Sciences and a Master of Science in Food Safety & Quality Assurance (FSQA), both degrees from the University of Guelph.
During her graduate studies she focused on developing a better understanding of her QA role, as well as the safety issues pertaining to health products. She was also able to communicate relevant FSQA issues through a Research Internship at the Food Safety Network and a Graduate Teaching Assistantship for FOOD*6300: Food Science Communication.
Tania has successfully navigated the ever-changing Canadian regulatory environment at her previous role at NOW Foods Canada/Puresource Inc. as a Product Licensing & QA Associate and in her current position at Nutrasource Diagnostics Inc. as a Regulatory Affairs Specialist, having collectively licensed over 50 products.
Tania sits on the Council of Responsible Nutrition’s (CRN) Regulatory Affairs Committee and is actively involved with the Canadian Health Food Association (CHFA), serving on their GMO Working Group, Organic & Food Advisory Council, and Communications Advisory Council. She enjoys mentoring individuals interested in the field and as such, was recently appointed as a part-time Instructor at the Academy of Applied Pharmaceutical Sciences.
Mr. Salendar Kumar
Manager, Regulatory Affairs – CMC
Hoffmann-La Roche Ltd.,
Salendar Kumar manages the Chemistry, Manufacturing and Controls group within the Regulatory Affairs department at Hoffmann-La Roche Ltd., executing all relevant critical evaluations of data, assessment and advanced identification of issues and establishing strategies for both biologic and synthetic portfolios at various stages including New Drug Submissions to post approval changes.
Salendar has held various positions in technical and regulatory management capacity in Brand and Generic industry and as well with Health Canada as a drug submissions reviewer. With a very strong knowledge of both synthetic and biological evaluation, drug development, technical support, manufacturing and technology transfer expertise, Salendar has been responsible for successful filing and approval of several New Drug Submissions.
As an ex-TPD Drug Reviewer, Salendar has in depth knowledge of Health Canada’s drug review process and has also established, built and maintained very productive relationships with agencies such as TPD, BGTD and FDA.
Salendar Kumar is a graduate of University of Toronto with over 14 years experience in Pharma and Biotech industry.
Mr. Mark Llewellyn, MA
Mr. Llewellyn is a graduate of the University of Toronto, from which he received the Master of Arts degree, specializing in Psychology. In addition, he studied behavioral pharmacology at the University of Michigan [at Ann Arbor].
Prior to becoming a consultant, Mr. Llewellyn did academic research on drug abuse, as a behavioural pharmacologist at the Ontario Addiction Research Foundation.
Mr. Llewellyn has over 32 years of experience as a marketing research professional, and is Managing Director of his own consulting agency that specializes in pharmaceutical market research.
Mr. George Markus, M.Sc.
Senior Director of Regulatory and Scientific Affairs
After obtaining his undergraduate B.Sc. Honours degree in Theoretical Chemistry (Dalhousie University) and his Master’s Degree in Analytical Chemistry (McGill University), George E. Markus spent the next 22 years participating and leading almost all areas of the scientific arena. His expertise encompasses Quality Control, Quality Assurance, Regulatory and Technical Affairs, R&D, Clinical Research and Medical Affairs. As Program Instructor/Professor, he has developed and presented a number of courses for the Academy of Applied Pharmaceutical Sciences (AAPS). He is a senior director of regulatory and scientific affairs at Generix pharmaceuticals
Mr. Geoffrey Marsden P.Eng
MGN Engineering Inc.
Over 15 years specializing in pharmaceutical industry calibration has given Geoff the opportunity to work with companies such as GSK, AstraZeneca & Biovail, Novocol, Wellspring, Aventis Pasteur, & Apotex.
Currently the principal of his own engineering firm, Geoff continues to work with leading pharmaceutical companies providing calibration & validation services, training and consulting. Geoff was educated in the United Kingdom and Canada. He is an Ontario licensed professional engineer and holds a degree in Electrical Engineering & Management from McMaster University in Hamilton, Ontario. Geoff currently teaches the calibration program at AAPS
Dr. Mary Mazur-Melnyk, Ph.D.
Chief Scientific Officer
Dr. Mary Mazur-Melnyk was educated in Toronto and holds a M.Sc. in Medical Sciences and a Ph.D. in Molecular Biology. She brings to the table over 20 years of experience in Biologics, Medical Devices and Biopharmaceutical industries. She has held senior level position in the areas of Regulatory Affairs and Quality Assurance at Aventis Pasteur, GSK, Novartis and most recently for Biovail Corporation as their Corporate Vice President of Quality. Currently, she is a Chief Scientific Officer with Innovalinks Quality Consultants (IQC), which specializes in the areas of Regulatory and Quality systems. She has extensive experience in the areas of technology transfer, R and D streamlining, and global regulatory approvals of NCEs.
Dr Pauline McGregor CChem MRSC, Ph.D.,
Pauline McGregor is a pharmaceutical consultant and owner of PMcG Consulting. She has over twenty five years’ experience in the Pharmaceutical industry and holds a Ph.D in chemistry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Pauline brings the experience and ability to customise and install the quality systems required to allow new manufacturing and testing companies to operate to GMP regulations and review and improve on current quality systems to allow more efficient operations. She also brings a technical expertise to laboratories which enable her to assist them to develop analytical procedures, validate them and optimise efficiency with regards to laboratory operations in a QC environment. She is also a renowned trainer in her areas of expertise. She is a member of the Royal Society of Chemistry and is on the USP expert panel for verification and validation analytical procedures. She has experience in utilising her skill set in the UK, Canada, US, Jordan, Brazil and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses.
She is currently a member of the Royal Society of Chemistry, UK and a proud member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and is listed on the RSC Directory of Consultants.
Mr. David McSweeney,
SNC Lavalin Pharma
David McSweeney is a Validation Specialist with SNC Lavalin Pharma and has over 15 years of experience working in the R&D, Validation, and Compliance. His background expertise is in compliance and computer validation. He has worked on computer validation projects for companies such as GSK, Sanofi Aventis, Apotex, MDS, 3M,.. His computer validation experience includes process control systems, spreadsheet and database applications, and large IT systems such as LIMS, ERP, and Clinical Database Management Systems. He has worked to establish company frameworks for compliance of computer systems to applicable regulations, including 21 CFR Part 11. David currently teaches computerized system validation at AAPS
Mr. Eran Oz
Director, Technical Operations
After completing and graduating with his Biotechnology Engineering degree (B.Sc.Eng) from Ben Gurion University, Israel, Eran began his pharmaceutical career at a startup company as a researcher.
In 2003, Eran joined TEVA Pharmaceutical , Israel, as a Project Development Manager in the R&D division and was both directly and indirectly responsible for the development, executions , validations and launches of dozens of solids, semi-solids, nasal sprays , otic and ophthalmic products to the US, EU, CA and local market, as well as site transfers within TEVA sites across the world.
In 2007, Eran completed and graduated with his Master Degree in Industrial Engineering and Management (M.Sc.Eng). He was relocated to TEVA Canada, and has held several progressive management positions since in the Technical Operations group, where he is mainly responsible for the executions of Process Validation activities related to TEVA Canada solid dose products.
Ms. Terry Pilkey
Director of QA/QC
Experchem Laboratories Inc.
A Chartered Chemist, her career spans 30 years in the pharmaceutical industry. She started as a stability chemist at Sterling Drug and soon moved to Health Canada where she worked over 13 years in various capacities with the Health Product Branch Inspectorate (HPBI) in the Ontario region. Her expertise include Medical Devices Inspection, Drug GMP Inspection and Compliance issues. She is currently the director of QA/QC at Experchem Laboratories Inc. where she is responsible for overseeing and maintaining the GMP compliance of the chemistry and microbiology laboratory, Auditing, and providing Quality Control Services to importers and distributors.
She has a degree in chemistry from York University and a diploma in Pharmaceutical Chemical Technology from Seneca College.
Dr. Peivand Pirouzi, Ph.D., M.B.A., CCPE
Peivand holds a Ph.D. in Physiology and Biophysics from the School of Medicine, University of Sherbrooke (Quebec, Canada), a M.B.A. from American Business Administration Institute (Maryland, USA), and he is accredited by the Canadian Council of Pharmaceutical Education with certifications in Evidence Based Medicine, Psychiatry, and Management. His B.Sc. in Physiology and Cell Biology and M.Sc. in Neurophysiology and Psychophysiology were obtained from University of Pierre et Marie Curie (Paris, France), and his M.Sc. in Biology was obtained from University of Quebec in Montreal (Quebec, Canada).
Peivand’s industrial experience (Wyeth/Pfizer/ApoPharma/Apotex) covers the management of more than 40 international clinical studies for pre and post marketing phases and participation in pre and post marketing regulatory activities and strategic planning. Peivand provides companywide corporate and sales training on multitude of subjects.
Peivand’s academic experience includes medical research and teaching since 1991 at U of Quebec in Montreal (School of Biological Sciences), U of Montreal (School of Medicine), U of Sherbrooke (Faculty of Sciences), Humber Institute of Technology and Advanced Learning (School of Health Sciences) and Seneca College of Applied Arts and Technology (School of Social Worker and Immigration and Faculty of Continuing Education). As a professor in graduate and post graduate programs, Peivand’s experience includes teaching Pharmaceutical Clinical Research and Regulatory Affairs, Quality Control and Audits, Compliance, Bioethics, Clinical Pharmacology, Psychiatry, Psychophysiology, Neurophysiology, Medical Biochemistry, Microbiology, Microbial Ecology, Virology, and Genomics.
Peivand has authored more than 65scientific realizations, including 12 publications in National Library of Canada, articles in peer-reviewed journals, oral and poster presentations, and more than 1000 technical and scientific reports. Every year, Peivand mentors more than 120 postgraduate students in Clinical Research and Regulatory Affairs.
Peivand has received several awards and recognitions including “A Scientific Recognition and Award” from His Very Honorable Bernard Landry, the Prime Minister of Quebec, Canada in 1995 and a letter of commandment from the Dean, School of Health Sciences, Humber Institute of Technology and Advanced Learning for teaching excellence in 2008.
Peivand is actually teaching at Advanced Academy of Pharmaceutical Sciences (AAPS), Humber Institute of Technology and Seneca College of Applied Arts and Technology in Clinical Research and Regulatory Affairs programs and is an independent consultant.”
Mr. Victor H. Shulman, Dip.Pharm, M.PharM.S.
Darvic Consulting Inc.
3rd generation pharmacist with over 40 years industrial experience in industry & GMP Compliance
Diploma in Pharmacy from the Witwatersrand Pharmacy School – Equivalent to a B.Pharm Degree
Registered Pharmaceutical Chemist and Member of the Pharmaceutical Society of Great Britain
Damelin Management School of South Africa – Diploma in Production Management.
Learned the art of Pharmaceutical production with 10 years “hands on” experience in South Africa. Immigrated to Canada in 1975 and worked for various Pharmaceutical companies BOTH Brand name & Generic.
In January 1999 – decided to take Semi-retirement to consult and Train Operators in the Pharmaceutical Industry.
Ms. Mia Spiegelman, B.Sc., RAQC
National Regulatory Affairs and Quality Assurance Director
Cardinal Health Canada
Mia Spiegelman was educated in Israel, Argentina and Toronto and holds a B.Sc. in Chemistry from York University and a Post Degree Certification if Pharmaceutical Regulatory Affairs and Quality Assurance from Seneca College. She brings to the table 11 years of experience in Generic Drugs, Medical Devices, Cosmetics and Natural Health Products. She has worked in various companies and has dealt with various product lines such as endoscopes, Dialysis Machines, Importation and distribution of all classed of regulated products as well Service Departments for the Medical field. Currently, she is a National Director for RA/QA in Canada’s leading and only national full service and value add distributor for Medical, Surgical and laboratory products – Cardinal Health Canada.
Mr. Swamy Subramanian
Manager, Regulatory Affairs
Cobalt Pharmaceuticals Company
Swamy is a trained pharmacologist, and an experienced regulatory affairs professional with more than 10 years of experience in the pharmaceutical industry. Currently, he leads a team of experienced regulatory affairs associates at Cobalt Pharmaceuticals Company responsible for preparation and filing of pre-market applications for subsequent entry pharmaceutical products to Health Canada. His expertise in regulatory affairs includes development of regulatory strategies for pre-market applications, and the Chemistry, Manufacturing and Controls (CMC) aspect of new product development. He has successfully filed several Abbreviated New Drug Submissions (ANDS) and has also been involved in the life cycle management of various products.
In addition to subsequent entry pharmaceuticals, Swamy also has experience working with innovative drugs and is conversant with the drug development process. In addition to Canada, Swamy has worked on regulatory filings for various international jurisdictions, including Middle East, South East Asia and South Asia. Prior to coming into regulatory affairs, Swamy was involved in research in pharmacology investigating the pathophysiological effects of diabetes in animal models. He has published many peer-reviewed publications in international journals, including a book chapter on diabetes, and presented posters of his research work at various international conferences.
Swamy has an undergraduate degree in pharmacy and Master’s degrees in pharmacology from India and the University of British Columbia. In addition, he has a post graduate certificate in regulatory affairs from Seneca College of Applied Arts & Technology in Toronto.
Mr. Andy Tallevi
Andy Tallevi is a Formulation/Process Consultant for Keller Consulting in Mississauga, Ont., Canada. He has 28 years of industrial experience, primarily in the Pharmaceutical industry. He currently consults clients in the Pharma and chemical industries assisting them with formulation and process issues and is an instructor at AAPS.
Most recently Andy spent 1 year with Health Canada in the Bureau of Pharmaceutical Sciences reviewing and evaluating generic submissions and making recommendations for approval or refusal of Notice of Compliance for the Bureau. He has gained significant insights to the regulatory requirements and expectations of the drug substance and drug product sections of a submission filing to Health Canada. In addition, he has an excellent understanding of the regulatory requirements for pharmaceutical development, the GMP requirements expected for pharmaceutical manufacture and has assisted former employers numerous times in audits by Health Canada and the FDA.
Prior to this, Andy worked as a Senior Pharmaceutics Scientist for GlaxoSmithKline in Canada. During his 18 years with the company he led many projects developing new chemical entities in varying dosage forms. His specialty is solid oral dosage forms. He and his team successfully formulated immediate release tablets as well as many controlled release versions of GSK new chemical entities. He has experience with conventional matrix approaches as well as proprietary technologies such as Procise® and DiffCORE®. He has been responsible for overseeing the manufacture of clinical supplies of NCEs both in Canada and at other GSK sites in Europe and the US.
Andy also has a solid understanding of material properties required of excipients and actives for successful formulation and for robust processes. He is well versed on particle sizing and powder flow. He holds a US patent on a novel approach for the assessment of the flow of pharmaceutical powders.
Prior to leaving GSK he was heavily involved in a company-wide effort to strengthen its processes by Design for Manufacture through the use of PAT and experimental design for which he was the lead user in Mississauga.
Prior to GlaxoSmithKline Andy worked as a scientist for Unilever developing products in the health, beauty and detergent industries. He graduated from the University of Toronto with a B.Sc. major in Chemistry.
Andy lives in Mississauga with his wife and 2 children.
Dr. Ravi Tan, PhD
Manager, Analytical Development
During his 14 years in the pharmaceutical industry, Dr. Tan has gained significant experience in the development and validation of analytical methods for brand & generic pharmaceutical products.
As a Senior Research Chemist at Genpharm Ltd., Ravi developed analytical methods for new Canadian, U.S. and international drug products. He also acquired a strong knowledge in the use of a broad range of analytical instruments including HPLC GC, IR, UV, NMR, DSC, TOC, particle size analyzer, and dissolution apparatus. His analytical and report writing skills have provided him with the opportunity to support the Canadian Regulatory Affairs department in the response to deficiency letters, NON and clarifax.
In his role as laboratory supervisor & associate manager at Patheon, Ravi provided direction to the scientists responsible for cleaning/ process validation, stability testing and method transfer and validation. Dr. Tan’s pharmaceutical and R&D experience allowed him to provide Patheon’s clients with a technically sound approach to product development. He was also responsible for providing analytical support to the development interface and the implementation of innovative methodologies and techniques for analytical development of drug substance and drug product development up to the NDA phase.
In his current role as Manager, Analytical Development at Cobalt Pharmaceutical, he directs the activities of the Analytical Development Laboratory and oversees all analytical development services as well as product bio batch release. His pharmaceutical and R&D experience allows him to provide guidance on analytical development and pre-formulation activities.
Ravi has received his Ph.D in Organometallic Chemistry from Leeds University (Leeds, UK). He completed postdoctoral fellowship at University of StrathClyde (Glasgow, Scotland). Ravi’s research interests are focused on the natural product synthesis, Organometallic and radical chemistry.
Mr. Pirouz Yousefian, M.Sc.
Food Safety and Quality
Pirouz Yousefian has over 17 years experience in the food industry working in various positions such as plant and operations manager, PD and Quality Assurance manager. He has been teaching Quality Assurance, Food Processing, Food Plant Sanitation, and Food Chemistry in Ontario Colleges and Universities. He provides consulting and technical support to food and allied industries.
His previous employment includes: Seneca College, Centennial College, University of Ryerson, Max Soy Canada, Kisko Products and Novopharm. He holds a M.Sc. in Food Science from University of Guelph.
Mr. Farzad Yousefian
Food Safety and Quality
Farzad Yousefian completed an Hon.BSc. in Molecular Biology and Microbiology at the University of Toronto. Upon the completion of his bachelor degree he completed a MSc. in Molecular Genetics, also at the University of Toronto. His thesis involved studying regulation of mRNA stability in Drosophila melanogaster ovaries during early development. Farzad has over ten years of Laboratory experience as his involvement has ranged at various levels including as a Volunteer, a Research Student, and a Technician. For the past three years he has been teaching at both Centennial College and the Academy of Pharmaceutical Sciences (AAPS). The courses he has taught include Food Chemistry, Food Microbiology and Safety, Food Product Development, Microbial Genetics, Systematic Microbiology and Environmental Microbiology.