- Ms. Noura Abdul, RD, CDO, OPDQ
- Mr. Ehsan Adiban
- Mr. Hassan Askary, PhD
- Ms. Barbara Allen
- Ms. Sara Berdugo, MAN, RD, CDE
- Ms. Stephanie Boville, M.Sc., RD
- Ms. Amanda Cannell, BSc.H., CCRP, PMP
- Ms. Beatrice Cardone, M.Sc., CCRP,
- Ms. Irene Cheung,
- Dr. Domenic Cianflone, BCom, MBA, PhD, CMA
- Mr. Jason Chu, B.Sc
- Mr. Danny Dean, MBA
- Mr. Sean D’Souza, BSc. CP-FS
- Dr. Sahba Eftekhary Shirkoohy, MD, MPH, MHA, CHE, PMP, PhD Candidate
- Dr. John Eisenhoffer
- Ms. Anita Ferrari
- Mr. Dan Hiltz
- Ms. Samantha Jackson
- Ms. Tania John, B.Sc., M.Sc.
- Mr. Salendar Kumar
- Ms. Marie Lippens
- Mr. Mark Llewellyn, MA
- Mr. Geoffrey Marsden P.Eng
- Dr. Mary Mazur-Melnyk, Ph.D.
- Dr. Pauline McGregor CChem MRSC, Ph.D.,
- Mr. David McSweeney
- Mr. Eran Oz
- Ms. Terry Pilkey
- Mr. Dinesh Puravankara, M.B.A, M.Sc, CPIM
- Mr. Victor H. Shulman, Dip.Pharm, M.PharM.S.
- Ms. Mia Spiegelman, B.Sc., RAQC
- Mr. Swamy Subramanian
- Mr. Andy Tallevi
- Mr. Steven Tanner
- Dr. Ravi Tan, PhD
- Mr. Paul J. Varady, B.Sc.
- Ms. Deseree Wong, BSc, MBA
- Mr. Pirouz Yousefian, M.Sc.
- Mr. Farzad Yousefian
“Best in Industry” Faculty
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.
Noura Abdul is a Registered Dietitian (RD) and a member of the College of Dietitians of Ontario (CDO) and l’Ordre Professionel des Diététistes du Québec (OPDQ) including the Dietitians of Canada.
Noura always had a passion for healthy eating and a better lifestyle. In her first undergraduate studies in psychology, she was working as a Specialized Educator for a mental health clientele. After completing her BA in psychology at the Université de Montréal, her interest in nutrition became more evident when she noticed that some of her clients were suffering from eating disorders leading her to continue her academic studies in nutrition. During her nutritional studies, her interest for mindful eating helped people enjoy food peacefully. Despite her interest in eating disorders, Noura also developed a significant passion for clinical and sports nutrition. Noura’s appreciation for the variety of cultural meals worldwide has bestowed on her great knowledge about the significant impact of nutrition and dietetics in a lifestyle. As a motivated and passionate RD, Noura finds joy in helping people setup and achieve their optimal nutritional goal and health in a reasonable, efficient approach and helping improve their quality of life.
After completing her undergraduate studies in nutritional sciences (BA), Noura started conducting nutritional research during her Masters in Interdisciplinary Health Sciences at the University of Ottawa. The aim of the projects was focused on nutritional deficiencies during pregnancy and its impact on the offspring’s behaviour and auditory functions, making Noura’s interest more evident towards nutrition and pregnancy.
Noura is also a Teaching Assistant at the University of Ottawa. The remarkable education and teaching experience help her provide better assistance in her current work field. She helps students with assessments and projects. She also prepares and provides presentations to students related to nutrition and other social and health fields such as psychology and microbiology.
During her graduate studies, Noura founded Shero NutriClinic, a private nutritional and dietetic practice with an emphasis on eating disorders, weight management and pregnancy but not limited to any other nutritional and diet related health conditions. SNC is located in Pickering, ON with services offered through out the GTA.
Noura also works as a Dietitian at Womens Fitness Clubs of Canada in Pickering, ON. She enjoys working with women and provides nutritional education and counselling for mainly weight loss management but not limited to other health conditions related to food and nutrition. Noura constantly works with personal trainers to help optimize better results for her clients. Her efficient and positive collaboration in a multidisciplinary team makes the world of nutrition and physical activity not only complementary, but keeps it also balanced.
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.
Barbara has over 25 years R&D experience in the pharmaceutical industry including GlaxoSmithKline, where her primary responsibilities included management of formulation and analytical development delivering R&D products from developability, first time in human, to full commercial transfer to manufacturing sites. During her career, she managed the diagnosis and rectification of complex CAPA investigations using lean sigma principles, change control, site manufacturing and facilities validation, analytical validation, analytical method development and stability programs.
She is currently a professor in Pharmaceutical and Chemistry courses at both Seneca College of Applied Art’s and Technology, Durham College, AAPS. Barbara obtained her MSc in Biochemistry and BSc with a specialist in Biochemistry and major in Chemistry from the University of Toronto.
Hassan Askary, PhD, is a Regulatory Affairs professional and has 20 years of experience in Biotechnological and Pharmaceutical industry in R&D, quality, validation and regulatory affairs with professional experience in United States and Canada. Hassan has extensive experience working in global regulatory environment and has worked with all major regulatory agencies. He has earned his Master of Science (MS) degree in Biochemistry from California State university, Fullerton, and his Doctor of Philosophy (PhD) degree in Management from Walden University, Minnesota.
In addition to instructing nutrition courses at AAPS, Sara works as a clinical dietitian in home care. She provides nutrition assessment, education, and counselling to adult and pediatric clients of CCAC (Community Care Access Centre) in their homes on a variety of topics, including cancer, tube feeds, diabetes, unintentional weight loss, wound healing, and swallowing difficulties. Sara also has clinical experience in community nutrition, diabetes education, and long-term care.
Sara graduated, with distinction, from University of Toronto with an Honours Bachelor of Science with majors in Nutritional Science and Physiology. She also graduated from Ryerson University, with honours, with a Bachelor of Applied Science in Nutrition and Food. Sara was awarded the Ryerson Gold Medal, Ryerson University’s highest honour, in recognition of high academic standing in combination with extensive participation in co-curricular activities. She completed her Master of Applied Nutrition degree at University of Guelph, which included her accredited dietetic internship with placements in a teaching hospital, long-term care, and Family Health Team. She also received a certificate in Adult Education from Mount Royal University and is working towards a Geriatric Certificate at McMaster University. She is registered with the College of Dietitians of Ontario, as well as a Certified Diabetes Educator. She is also a member of Dietitians of Canada.
Sara has a passion for nutrition and food and is excited to share her knowledge and experience with the students at AAPS.
Stephanie graduated from the University of Guelph with an Honours Bachelor of Applied Science degree. She then followed her passion and completed her Masters of Science degree where she specialized in exercise, nutrition, and metabolism. Her research was focused on the effects of dehydration on thermoregulation, mental and physical fatigue in female ice hockey players. During her time there she was able to conduct hydration testing and exercise performance testing on various varsity, semi-professional and professional athletes. She then went on to complete her dietetic internship at London Health Sciences Centre and is now a Registered Dietitian with the College of Dietitians of Ontario and is also a member of Dietitians of Canada.
In addition to instructing the sport nutrition courses at AAPS, Stephanie is starting her own consulting business, focusing on athletes and nutrition for athletic performance.
Canadian Cancer Clinical Trials Network (3CTN)
Amanda Cannell has more than 10 years of experience working in clinical research and drug development, which includes roles in both the pharmaceutical industry as well as the academic hospital setting. Further to this experience, Amanda is currently the Manager, Operations for the Canadian Cancer Clinical Trials Network, which aims to support Canadian cancer centers with the necessary clinical trial infrastructure to conduct efficient cancer studies for the betterment of Canadian cancer patients.
Amanda holds a Bachelor of Science in Molecular Biology & Genetics from the University of Guelph as well as post-graduate diplomas in both the Clinical Research and Project Management disciplines. Amanda’s academic productivity includes co-authorship on 7 manuscripts as well as oral and poster presentations at many cancer research conferences. Moreover, Amanda volunteers as a member of the Mount Sinai Hospital Research Ethics Board and worked on the ethical review and approval of many clinical trials in various therapeutic areas. By joining the faculty at AAPS, Amanda strives to share her passion for healthcare innovation and her in-depth knowledge of the clinical research industry with present and future AAPS students.
Beatrice is the Clinical Research Manager at Xagenic Inc., a Toronto based biotech innovator of Point of Care Diagnostic tests. She has extensive experience in the Project Management of Pharmaceutical Clinical Trials and Clinical Trials for the Medical Device Industry. In previous roles, Beatrice was a Clinical Project Manager at Pharma Medica Research Inc., a Toronto based Clinical Research Organization, where she managed over 50 Phase I and II Pharmaceutical clinical trials. In previous roles, she was the Project Manager, Product Development at International Point of Care and the Laboratory Manager at Spectral Diagnostics, which both specialize in point of care diagnostic devices. Beatrice holds a Master of Science in Neurochemistry from the University of Toronto, and Post Graduate Diplomas in Clinical Research, Medical Laboratory Technology, Adult Education and Project Management.
Irene Cheung is an instructor for the Nutrition, Health and Sport Diploma Program at the Academy of Pharmaceutical Sciences. She completed her bachelor’s degree in Community Nutrition at the University of Western Ontario and her Master’s by research work in Community Nutrition and Health Promotion at the Chinese University of Hong Kong. Following graduate school, she returned to Canada to become a Registered Dietitian. Since then, Irene has mainly worked in food security, community capacity building, public health research, nutrition counselling, and program planning/evaluation in Toronto and Edmonton. She has served clients from the less privileged, including the homeless and Aboriginals, to top public health officials, namely Medical Officers of Health. While she has received public recognition from front-line to senior managers and community leaders, it is the private recognition from her less privileged clients and dietetic interns that she finds most dear. Her main interest in life includes improving the health and welfare of the community, animals, friends, and family through pro bono or volunteer services.
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
Jason Chu is an experienced laboratory instructor at AAPS focusing on quality control and research and development functions in the pharmaceutical industry. He is an expert in HPLC, Dissolution, Pharmaceutical Laboratory Tests and GMP regulations. Beyond the classrooms at AAPS, he has led corporate training covering topics on WHMIS, health and safety, GMP regulations and data integrity.
Prior to joining AAPS, he was an Analytical Research and Development Chemist at Apotex Inc. – task with laboratory investigations, method validation, API screening and process validation support. During his time in R&D, he was appointed as a Designated Compliance Coordinator (DCC) to conduct regularly scheduled self-audits for continuous compliance improvement. At Apotex, he also held position as a Quality Control Chemist – testing raw materials, in-process products, finished products using a variety of laboratory techniques and instruments. In that role, he was also designated as a Subject Matter Expert (SME) task with responding to audit requests conducted by Health Canada and FDA.
Before starting his career at Apotex, Jason earned his B.Sc in Chemistry from York University (2008) and continued as a research assistant specializing in Synthetic and Analytical Inorganic Chemistry. His projects primarily focused on electrochemical reduction of CO2 to useful fuels and structure elucidation of novel complexes. During his time at York University, he taught various undergraduate laboratories in Organic, Inorganic, and Analytical Chemistry as a teaching assistant.
He brings with him wealth of teaching and GMP laboratory experience and a thorough understanding of process validation, cleaning validation testing, analytical techniques as well as regulatory requirements in the pharmaceutical industry.
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.
Sean D’Souza has over 15 years of experience in a variety of roles within the food industry and hospitality sector ranging from Chef, Catering Manager, Quality Assurance and Control, Food Safety Consultant and Trainer.
From his experience at his various roles, Sean has developed a strong level of expertise involving food contaminations; food safety; transportation of food; packaging and labeling; cleaning procedures and personal hygiene; employee safety and training. He has audited, trained and consulted on multiple international and local restaurant, hotel and grocery chains throughout North America and the Middle East.
Sean holds a BSc. in Biology from York University, Culinary Management diploma from George Brown College and is also a Certified Professional in Food Safety (CP-FS) through National Environmental Health Association (NEHA).
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.
Dr. John Eisenhoffer is a medical professional with over 22 years of pharmaceutical industry experience in Drug Safety, Medical Information, Clinical Research and Medical Liaison. As the Canadian Drug Safety Head he developed and directed a highly functional team to meet all compliance standards in Drug Safety and Medical Information Services to complete many successful Health Canada Audits. He has also directed drug development for Canadian products, managing Phase I-IV clinical studies with successful approvals from Health Canada. Dr. Eisenhoffer has mentored graduates and Health Care Professionals in Drug Safety and Clinical Research as well as providing scientific education to Sales, Marketing, and prescribing Health Care Professionals. He was the Scientific representative on many life cycle product teams and provided scientific review and approval of marketing material. He was also the Medical Reviewer for the International Signal Evaluation Group and authored Risk Management Plans and Periodic Benefit Risk Evaluation Reports to support Canadian products. He has a very strong scientific background with 17 published peer reviewed papers.
He received his Medical training in Europe, and a Masters of Science from University of Toronto.
Currently Dr. Eisenhoffer is an independent consultant for the pharma Industry focusing on drug safety and clinical research.
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.
Dan Hiltz has led training and development initiatives in global corporations for over 25 years. At Convergys Corporation, he designed and implemented a learning platform for over 80,000 employees globally. Beginning in 2007, he transformed the learning and leadership development programs at Kendle International, a global clinical research firm, from a live, instructorled model to a blended, virtual learning environment. The success of this initiative was recognized by Training magazine, eLearning, and Chief Learning Officer. He’s the founder and principal of Leadership Squared, a training and coaching firm dedicated to helping organizations build strong, adaptive cultures. Dan is a graduate of Thomas More College in Crestview Hills, KY, and holds a masters and doctorate from the University of Notre Dame. He is a Gallup Certified Strengths Coach, a CompTIA Certified Technical Trainer (CTT+), and serves as a Commissioner of the International Association of Continuing Education and Training (IACET). He partners with Harvard Business Publishing, a division of Harvard Business School to include world-class
content in all Leadership2 programs.
His clients include:
- Western & Southern Financial Group
- US Navy Flight Demonstration Squadron (The Blue Angels)
- The Church of Jesus Christ of Latter-day Saints
- Healthcare Financial Management Association
- Pomeroy IT Solutions
- many others
Ms. Samantha Jackson is a PhD Candidate in Comparative Public Policy at McMaster University and a researcher at the Diversity Institute at Ryerson University. She completed her BA in Political Science and Middle East Studies at McGill University and MA in Immigration and Settlement Studies at Ryerson University.
At McMaster and Ryerson, Samantha has worked as a teaching assistant for a variety of courses in the social sciences and humanities. Samantha also has experience designing curricula and teaching English in the West Bank.
Samantha’s academic work has been published in the Journal of Refugee Studies, Queen’s Policy Review, and the Women in Leadership Around the World edited volume series. She has also published plain-language reports analyzing women in leadership in Hamilton (Women and Leadership EXCLerator Project), refugee healthcare and employment (RCIS Research Brief Series), and the Toronto Police Service’s implementation of human rights and diversity reforms (Evaluation of the Human Rights Project Charter).
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.
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.
Marie holds a B.Sc from the University of Guelph where she studied analytical chemistry and biochemistry. She also obtained an advanced diploma from Seneca College in pharmaceutical chemistry. Her career in the pharmaceutical industry spans more than 15 years. She started as a chemist at a contract pharmaceutical lab. Since, she worked in method development and validation, and then became an instrumentation specialist evaluating, commissioning and validating laboratory equipment for chemistry and microbiology labs. She has worked in pharmaceutical development, manufacturing, wet chemistry, chromatography, spectroscopy, quality assurance and training. She has led laboratory audits from both client and federal regulators.
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.
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
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 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.
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.
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
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 held several progressive management positions since in the Technical Operations group, where he was mainly responsible for the executions of Process Validation activities related to TEVA Canada solid dose products.
In January 2014, Eran joined the Apotex Pharmaceuticals Group in the capacity of Director, Global Technical Operations for all OSD sites.
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.
Regional Scientific and Regulatory Affairs Manager
For the last thirteen years Dinesh has been working for Coca-Cola LTD. Since 2013, he has taken on the role as a Regional Scientific and Regulatory Affairs Manager. As a Regulatory Affairs Manager he develops and executes regulatory strategies to secure market authorizations for fortified food products and beverages. His previous roles at Coca-Cola include Senior Quality Systems Auditor (Toronto, Ontario), Regional Audit Manager and Quality Assurance Supervisor (Richmond, British Columbia).
Dinesh has been acknowledged as an expert in Regulatory Affairs, Food Safety and Quality Management. Having worked as a Plant Supervisor for Lucerne Foods (Burnaby, British Columbia), a Manufacturing Chemist for Reena Enterprises (Toronto, Ontario) and a Production Supervisor for Nada Dairy (Saudi Arabia). He has demonstrated a high level of knowledge in Food Safety, Production Management, Regulatory Affairs and Quality Assurance.
Dinesh holds an MBA from the Segal School of Business at Simon Fraser University (Vancouver, British Columbia) as well as a M.Sc. in Dairy Chemistry from the Gujarat Agricultural University (India). He is an active member of the Canadian Beverage Association as well as the American Society for Quality (Milwaukee, Wisconsin). His previous involvements include a membership with the International Society of Beverage Technologists (ISBT) (Dallas, Texas) and the Canadian Institute of Food Science and Technology (Toronto, Ontario).
With such outstanding professional experience, impressive academic accreditation and active participation within the Food Safety, Technology and Quality industries, AAPS is happy to welcome Dinesh as an instructor for the Food Quality Assurance and Quality Control program.
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.
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.
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.
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.
Mr. Steven Tanner has worked for and partnered (GQRP) with the top global pharmaceutical manufacturing, contract research, wholesale and specialty distribution organizations in both Europe and North America. From Eli Lilly UK to Merck KGaA (now Mylan) in Canada, Pharmanet (now Inventiv Health), Teva, and the McKesson Corporation, Steven now surpasses more than 17-years of progressive GxP industry experience in quality, compliance and technical training senior leadership roles.
Steven’s specialties include leading FDA and Health Canada GMP inspections, customer 3rd party logistics (3PL) quality & qualification audits, as well as the hands-on design, strategy, execution and management of GxP regulatory quality systems: change controls, deviation controls, CAPA, validation/21 CFR Part 11, document controls, environmental monitoring, complaints, equipment & shipment qualifications, SOPs, technical writing, drug recalls, quality agreements, self-inspections. Steven has also partnered since 2004 with AAPS – Academy of Applied Pharmaceutical Sciences where he’s provided quality assurance/GxP technical facilitation. In 2016 Steven accepted a full-time role as Campus Manager and Director of Student Affairs with AAPS.
Steven graduated in 1999 with an honours degree in Chemistry from Leicester University in the United Kingdom and holds a postgraduate diploma in Adult Education from St Francis Xavier University, Nova Scotia, Canada.
Paul has over 20 years of experience in the Pharmaceutical Industry, predominantly in the field of Regulatory Affairs. Paul’s experience in Regulatory Affairs includes Canada and the USA and involves innovative drugs, generics, NHPs and veterinary drugs. Paul’s insight is multifaceted. He has been involved in product development and regulatory navigation for multinational innovative and generic companies as well as small private companies, which included working as a consultant supporting a multitude of different clients and situations. Paul’s career has lead to creation of RegCon Solutions, a company that provides experience and knowledge for growing and establish companies focused on the Canadian market. Paul has also spent the last 6 years sharing his experiences and knowledge teaching Regulatory Affairs and pharmaceutical related topics at Seneca College, Humber College and AAPS.
With over 10 years of experience in Clinical Research, Deseree has held multiple roles in clinical operations including Clinical Study Coordinator, CRA and Study Manager. She has managed studies in Oncology, Immunology and vaccines for companies that include GSK, Amgen and Quintiles. Deseree is currently a Project Manager at Topstone Research, a full service CRO.
Deseree Wong has an honors BSc in Pharmacology and Toxicology from the University of Western Ontario and an MBA from the University of Toronto.
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.
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.