2019 APEC CoE Pilot Training on Supply Chain Security for Medical Products
DR. LANE CHRISTENSEN
ASSISTANT COUNTRY DIRECTOR
FDA CHINA OFFICE
Dr. Lane Christensen is an Assistant Country Director of the China Office in the Office of Global Policy and Strategy (OGPS) at the US Food and Drug Administration (FDA) where he serves as the International Program and Policy Analyst (IPPA) for Drugs. Before joining the FDA China Office, he was a Branch Chief in the Office of Process and Facilities (OPF), in the Office of Pharmaceutical Quality (OPQ), CDER, FDA which is tasked with the review of manufacturing process and established facility inspections for abbreviated and new drug applications (A/NDAs).
Previously he was with the Office of Generic Drugs (OGD) as a Team Leader in a review division and as a Chemist with the Immediate Office having various responsibilities related to Chemistry Manufacturing Control activities such as ANDA review, Control Correspondences, Citizen Petitions, and policy development. Lane was extensively involved in various initiatives related to OPQ reorganization and new user fee implementation under GDUFA. He received his Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah followed by a post-doctoral fellowship within the pharmaceutical industry. Lane began his FDA career with the CDRH Office of Compliance.
TONY ORME
LEAD SENIOR GDP INSPECTOR
INSPECTION, ENFORCEMENT AND STANDARDS
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
A founder member of the UK GDP Inspectorate when it was created in 2001, he is a Senior GDP Inspector responsible for inspecting the full range of UK distribution companies. He was a member of the PIC/S GDPworking group, working on the training and aligning of GDP standards for PIC/S member countries. He was part of the EMA GDP drafting group preparing the GDP Guidelines and updates to the compilation of community procedures and involved in training the GMDP inspectors on the new guidelines. He is currently a member of the implementation team for the Falsified Medicines Directive and closely works with the Enforcement team looking at supply chain integrity. He has contributed to previous APEC supply chain training in Memphis and Seoul.
PROF. DR. MURALI SAMBASIVAN
PROFESSOR TAYLOR’S BUSINESS SCHOOL,
FACULTY OF BUSINESS AND LAW
TAYLOR’S UNIVERSITY
Prof Murali has more than 20 years of teaching experience and 10 years of industry experience. His research interests are in the areas of Management Science, Operations Management, Supply Chain Management and other areas of management. He is currently working as a Professor at Taylor’s Business School at Taylor’s University Lakeside Campus, Malaysia.
Prof Murali has published more than 100 articles in many international refereed journals of repute such as International Journal of Production Economics, Journal of Cleaner Production, Technovation, Computers and Operations Research, International Journal of Physical Distribution and Logistics Management, International Journal of Project Management, International Journal of Hospitality Management, International Journal of Medical Informatics, Journal of Biomedical Informatics, BMC Journal of Medical Informatics and Decision Making, PLoS One and many more. He has supervised/co-supervised more than 60 PhD and MSc students. Prof Murali obtained his PhD in Management Science from University of Alabama at Tuscaloosa, USA and his degrees in Engineering from India. He worked in the industry for 10 years before becoming an academic.
BRETT MARSHALL
CORPORATE HEAD
QUALITY ASSURANCE
ZUELLIG PHARMA
Brett Marshall is the Corporate Head, Quality Assurance for Zuellig Pharma, the largest healthcare services group in Asia. Based in Singapore, Brett has direct reporting lines from Quality Assurance Heads in 13 Countries and Quality oversight of Clinical Reach Operations in another 4 Countries. Originally from Melbourne, Australia, Brett has a Bachelor Degree in Transport & Logistics Management from RMIT. He has 25 years’ experience in Executive Management, Logistics & Supply Chain, Business Process Transformation and Quality Assurance, 15 years in the Pharma Industry, and more than 20 years living in Asia – in Indonesia, Thailand, the Philippines, Bangladesh and now Singapore.
CHLOE LEE
MARKET ACCESS
ROCHE SINGAPORE PTE. LTD.
Chloe has taken up various roles across within Quality, having workedin manufacturing sites as an auditor and most recently as the APAC Supply Chain Quality Manager in Roche. In her current role, she is responsible for providing the quality oversight and expertise in the area of the distribution and logistics of finished products in the region. She believes strongly that Quality is not about enforcing but cultivating the right mindset. Ultimately, all of us are working towards the well-being and the benefits of patients. By ensuring well-controlled supply chain, we can be confident that patients will always receive safe, authentic and quality products.
NOR HAFIZAH BINTI MOHD POTRI
SENIOR PRINCIPAL ASSISTANT DIRECTOR
NATIONAL PHARMACEUTICAL REGULATORY AGENCY, MALAYSIA
Nor Hafizah had obtained BPharm (Hons) degree from University Malaya, Malaysia. She then started her career as a House Pharmacist at National Pharmaceutical Control Bureau (NPCB), Malaysia and progressed to an Assistant Director at the Licensing and GMP Unit, Centre for Good Manufacturing Practice (NPCB), then to a Senior Assistant Director of GMP Section (Pharmaceuticaland Veterinary Unit), Centre for Compliance and Licensing (NPCB), and later to a Principal Assistant Director of GMP Section (Pharmaceutical and Veterinary Unit), Centre for Compliance and Licensing (NPCB). She is currently the Senior Principal Assistant Director, GMP Section (Pharmaceutical and Veterinary Unit), Licensing Section and GDP Section, Centre for Compliance and Licensing, (NPRA).
She has numerous publications on GMP and GDP. She was also appointed as GMP Auditor on 1st January 2004 and Lead Auditor on 1st June 2009, Internal Auditor for NPCB/NPRA ISO Quality Management System since 2006 – 2014 and 2019, Internal Auditor for NPCB 5S/EKSA Program since 2010 – 2015 and is a Recipient of ’Anugerah Perkhidmatan Cemerlang’ (Excellent Service Award) from Ministry of Health Malaysia (2008 & 2013).
SENTHIL RAJARATNAM
AFFILIATE RELATIONS MANAGER
GLOBAL SERIALIZATION PROGRAM ELI LILLY
Senthil obtained his Bachelor of Science, Mathematics from the University of Madras, India. He also has a Master of Science, Computer Applications from Anna University, India. He has over 16 years of experience in Pharmaceutical industry and has played various roles in IT, Supply Chain and Manufacturing organizations.
He is the global strategy and implementation leader for Serialization, Track and Trace and Unique Device Identification (UDI) for Eli Lilly to comply with legislative requirements in various countries. His expertise is on GS1 Standards, Serialization technologies and systems, barcoding, global harmonization of standards and best practices. He is an industry thought leader for product traceability policies, technologies that support traceability implementations and looking out for opportunities that can create business value beyond compliance by leveraging emerging technologies such as blockchain. He was a speaker in many industry conferences, which were attended by members of the industry and regulatory bodies and had presented on topics related to global harmonization of serialization and traceability requirements.
MARCEL DE GRUTTER
LIAISON REGULATORY & GOVERNMENT AFFAIRS
ABBOTT
With over 30 years’ experience in pharmaceuticals, Marcel has held various positions and roles, was actively involved in reorganizations, integration, and separation after takeovers and business splits. As a world-renowned and respected expert in MOMS, Operations, IT and Serialization Track & Trace, he is able to translate regulatory and business requirements to practical, cost effective, innovative automation, and IT solutions. In addition to being active in various industry groups, and Board Member and speaker at many congresses, Marcel is also Executive Director of the non-profit OPEN-SCS Serialization Communication Standards Group.
LEANDRO OLIVEIRA
SR. MANAGER
SUPPLY CHAIN IDENTIFICATION & TRACEABILITY
JOHNSON & JOHNSON
Leandro Oliveira has spent most of his career in the supply chain area and the last 4 years specifically on pharmaceuticals serialization and traceability programs. He works at Johnson & Johnson since 2009 and currently responsible for Product Identification & Traceability, Unique Device Identification and other GS1 related programs in the Asia Pacific region. He also worked previously in different IT and Engineering functions at Energy, Oil and Gas industries, managing projects in Europe and Middle East. He has B.S. degree in System Analysis, MBA in Project Management by FGV Brazil and UCI United States, also holds PMP and APICS CSCP certifications.
CHAN KUEN LAM
SENIOR MANAGER
SERIALIZATION APAC
PFIZER
With background in information technology and supply chain management, CK has been working on ERP and supply chain project management in regional capacity for over 20 years. Past companies include APL and Warner Bros. CK joined Pfizer Business Technology in 2012 and later moved to current role as Senior Manager Serialization APAC responsible for serialization solutions and market engagement in Asia under Pfizer Global Serialization Program. CK holds a Bachelor of Arts in Computing from Hong Kong Polytechnic University, Project Management Professional (PMP) and Six Sigma Black Belt. Passionate about nature, CK spends weekends hiking inthe beautiful countryside of Hong Kong.
MOHD AZUWAN MOHD ZUBIR
SENIOR PRINCIPAL ASSISTANT DIRECTOR
PHARMACY POLICY & STRATEGIC PLANNING
MINISTRY OF HEALTH MALAYSIA
Mohd Azuwan graduated with a Bachelor of Pharmacy degree from the International Islamic University Malaysia (IIUM) in 2006. In 2015, he obtained a Master of Pharmacy Practice from the Universiti Teknologi MARA (UiTM). He started his career in Malaysia as a Provisional Registered Pharmacist (PRP) at Sarawak General Hospital, Kuching, after which he became an Assistant Director, Pharmacy Practice & Development, at the Sarawak State Health Department in 2007. From 2008 until 2017, he was part of the Pharmacy Practice & Development Division at Ministry of Health Malaysia (last position as the Principal Senior Assistant Director). Currently, he is the Senior Principal Assistant Director of Pharmacy Policy & Strategic Planning Division at Ministry of Health Malaysia.
JEFFREY GREN
BOARD MEMBER
ALLIANCE FOR SAFE ONLINE PHARMACIES (ASOP GLOBAL)
Jeffrey Gren is Member of the Board of Directors for the Alliance for Online Pharmacies (ASOP Global); President, Gren International Trade & Health Consulting; Member of the Advisory Board for the APEC Harmonization Center; and Senior Consultant for The Webster Group. As an ASOP Board member Mr. Gren has led efforts to organize China,India, Brazil, Mexico and APEC events focused on combating illegal internet drug sales and promoting safe medicines. Served with China FDA as Co-chair of the APEC RHSC Drug Detection Technology Working Group and as a member of the APEC RHSC Internet Sales Working Group.
In 2014 Mr. Gren transitioned from a long and distinguished career with the U.S. Department of Commerce (DOC) where he served as the Director of three offices with a medical devices and pharmaceutical industry focus. Major accomplishments include leading global activities to stop the spread of substandard and falsified medicines, serving as U.S. Co-chair of the Medical Devices and Pharmaceuticals Task Forces of the China – U.S. JCCT Pharmaceuticals and Medical Devices Subgroup, serving as nodal point for India and U.S. Department of Commerce health dialogues, organizing the an India International Forum on Drug Authentication Technologies and leading the organization of ASOP Global China, India, Brazil and Mexico delegation trips and symposiums.
Mr. Gren received a Master of Arts in Economics and a Bachelor of Science in Business Administration from Northeastern University in Boston and he has received numerous U.S. Department of Commerce, industry association and international organization medals and awards.
SITI MARIATON BINTI ABD MOKSIN
SENIOR PRINCIPAL ASSISTANT DIRECTOR
PHARMACY ENFORCEMENT DIVISION
MINISTRY OF HEALTH, MALAYSIA
Siti Mariaton Binti Abd Moksin graduated with a Bachelor of Pharmacy from the Universiti Sains Malaysia in 1998. In 2009, she obtained a Master of Enforcement Law from the Universiti Teknologi MARA (UiTM). Siti Mariaton had worked in the Pharmacy Services Division, Selangor State Health Department from 1999 – 2015 and is currently the Senior Principal Assistant Director at Pharmacy Enforcement Division, Ministry of Health Malaysia.
NORLIDA BINTI ABDUL RAHMAN
SENIOR PRINCIPAL ASSISTANT DIRECTOR
PHARMACY ENFORCEMENT DIVISION
MINISTRY OF HEALTH, MALAYSIA
Norlida Abdul Rahman graduated with a Bachelor of Pharmacy (Hons.) from the University of Malaya in 2000. In 2013, she obtained a Master of Science in Computer Science from the University of South Wales, UK. Norlida is presently the Head of Cyber Forensics Section at Pharmacy Forensic Branch in Pharmacy Enforcement Division, Committee of Intelligence & Operations and Committee for Cyber Pharmaceutical Task Force under Ministry of Health Malaysia. She is also a Member of Malaysia Digital Forensics Working Group, ASIAN Digital Forensics Working Group, Cyber Crime Task Force under NACSA and an Alternate Member of Pangea Steering Committee under INTERPOL. She had previously worked at Pharmacy Enforcement Branch, Pharmaceutical Services Division in Terengganu Health Department as Pharmacy Enforcement Officer from 2001 until 2015.
BEATRICE POH
TECHNICAL SPECIALIST
HEALTH SCIENCES AUTHORITY (HSA) SINGAPORE
Beatrice Poh is a Technical Specialist (Cybercrime Investigation) at the Enforcement Branch, Health Sciences Authority, Singapore. Her experience as a Technical Specialist (since 2002) include:
> Planning for and participating in operations/raids with team and other enforcement agencies.
> Worked as investigator for more than 10 years handling a wide range of functions e.g surveillance, investigation and putting up investigation papers.
> Responsible for handling and managing cybercrimes dealing with pharmaceutical products.
> Involvement in key international projects e.g. Ops Pangea coordinated by INTERPOL STORM Enforcement Network for ASEAN countries.
> Responsible for providing training in cybercrime investigation and have worked with Interpol as co-trainer to provide cybercrime training to ASEAN countries under the Storm Enforcement Network.
Beatrice has also conducted trainings as below:
> 2013 – Interpol Co-trainer for Indonesia NADFC in Singapore
> 2014 – Interpol Co-trainer for China Police and SFDA in Guangzhou
> 2015 – Interpol Co-trainer for Storm Enforcement Network Group in Singapor
> 2015 – Interpol Co-trainer for Myanmar MOH and Police in Yangon
> Speaker for Investigation & Prosecution Methods for Cyber Crime in Batu Pahat, Malaysia organised by Pharmacy Enforcement Department
RAMESH RAJ
REGIONAL MANAGER ASIA
PHARMACEUTICAL SECURITY INSTITUTE
Mr. Ramesh Raj is currently The Pharmaceutical Security Institute’s Regional Manager for Asia Pacific. He holds a Post Graduate Diploma in Law, University of London and Business Management & Administration (Honors) from the University of Bedfordshire. He served the Singapore Police Force for almost 18 years and is skilled in the areas of Criminal Intelligence gathering and Investigation into anti-counterfeiting.
Mr. Raj has a distinguished career with the Health Sciences Authority (HSA), Singapore. In August 2016, he was the Head of the Enforcement Operations Unit overseeing field enforcement activities, surveillance, seizure management and coordinated efforts with other law enforcement agencies (LEAs). His accomplishments included several successfully prosecuted landmark cases involving rouge medical practitioners and counterfeit medical devices. His working relationship with international organizations is excellent and dates to 2011 when he was a co-trainer for Interpol and has presented on the challenges of pharmaceutical crime to law enforcement agencies both in the Asia Pacific Region and Europe for many years.