APCER Pharma (“APCER”) is a global team of experienced, qualified professionals on the ground with Medical and Pharma qualifications and experience that spans North America, Europe & Asia. Within this global framework, APCER has built local teams of qualified professionals in different countries to strategically tap the best available resources in order to provide services to our customers.

We currently file Drug Safety & Regulatory submissions in 68 countries, have a team that performs end to end Pharmacovigilance & Regulatory services using best in class, Validated technology platforms and provide unsurpassed, timely & cost effective solutions to our clients. We have been inspected several times by Regulatory Authorities and “WE KNOW COMPLIANCE MATTERS!”

Below is a selection of our team members and advisors who are passionate about what they do and their belief that there can never be a compromise when dealing with compliance.

Dr. Vineet Kacker
Managing Director, APCER Pharma
Dr. Kacker is a Pharmacologist by training, having done a Ph.D in Pharmacology from All India Institute of Medical Sciences in India. Dr. Kacker switched his interests from academia to private industry nearly 10 years ago, and has managed the Regulatory and Pharmacovigilance functions at generic companies such as Ranbaxy (UK) Limited and PSI nv (a subsidiary of Jubilant Organosys Limited). Dr. Kacker has been a Qualified Person/Person Responsible for Pharmacovigilance first at Ranbaxy and then at PSI with experience of more than 7 years as QPPV. Dr. Kacker also has prior experience in setting up and managing global pharmacovigilance systems for these companies. He serves as QPPV for a number of clients in his current function at APC, and has successfully managed their compliance through various inspections.

Suneet Walia
President & CEO
Suneet Walia is a business leader and an entrepreneur with more than 13 years of operations, technology & finance experience in the healthcare/pharmaceuticals space. Suneet has hands on experience in structuring, planning and implementing global Pharmacovigilance systems. Additionally, Suneet has led the implementation of full lifecycle CTD/eCTD Regulatory platforms and built novel solutions leveraging best-in-class industry solutions in various Compliance areas in the Pharmaceuticals space.

Michael Reynolds
Head, Sales & Marketing, Europe, Asia & Africa
With a background in Microbiology, Michael has spent the last 20 years working for recognized global Pharmaceutical companies such as Bayer, Astra Zeneca and Braun or selling to them with differing software and services organizations. With his comprehensive understanding of both Regulatory and Safety systems and operations Michael joins APC from a clinical software company where he successfully ran the European Sales organization.

Dr. Barton Cobert
Pharmacovigilance Strategy & Client Services Advisor
Dr. Cobert is an expert on Drug Safety and Pharmacovigilance, and author of 3 textbooks on drug safety including The Manual of Drug Safety and Pharmacovigilance, used in training courses on drug safety and Pharmacovigilance. He has extensive experience in Drug Safety, Clinical Research, Regulatory Affairs, Risk Management, Compliance, Inspections/Audits, Data Management, and Informatics in drug safety and clinical trials. He is a frequent presenter at Drug Safety Meetings, DIA, PERI, Uppsala Monitoring Centre, Temple University, University of Montréal, has was one of the founding members of the International Conference on Harmonisation (ICH) starting in 1989. He has worked on several ICH Working Groups and co-chaired the PSUR update group. He has also had numerous safety articles published in refereed journals and is on the Editorial Board of Expert Opinion in Drug Safety. He was previously Global Head of Drug Safety at Schering Plough (1992-2003), Global Head of Safety at Novartis Consumer (2006-2007), and has held senior positions at Forest Laboratories, Hoechst Roussel Pharmaceuticals (now Sanofi-Aventis), Ives Laboratories (now Wyeth) and Medidata Solutions. Dr Cobert is a graduate of the New York University School of Medicine where he also did his training in Internal Medicine and Gastroenterology. He also did a post-doctoral fellowship in hepatology at Hopital Beaujon/INSERM in Paris, France. He is board certified in Internal Medicine and Gastroenterology. He is on staff at the NY University School of Medicine and the University of Medicine and Dentistry of NJ.

Dr. Chrisopher Metzler RPh, DPM
Vice President Safety & Pharmacovigilance Operations
Dr. Metzler has extensive experience in global pharmacovigilance and drug information systems compliance and auditing with an excellent level of understanding of current global pharmacovigilance legislation and guidance. Prior to joining APCER Pharma Solutions, Dr. Metzler was head of quality at Sentrx where he was responsible for hosting, conducting and responding to audits, management of SOPs and the quality system. As a member of Wyeth Pharmaceuticals' Global Business Compliance group he was responsible for auditing headquarters, affiliates, and business partners for pharmacovigilance, privacy, labelling, promotional and medical information practices against international laws and regulations and company policies and procedures. Dr. Metzler also spent nearly five years with Schering-Plough Corporation, holding positions of increasing responsibility in Drug Safety Surveillance Compliance, Operations, Training and Global Drug Information Services. Prior to entering the pharmaceutical industry, Dr. Metzler was a pharmacist and a practicing podiatrist. He graduated from Rutgers College of Pharmacy in 1984 and from New York College of Podiatric Medicine in 1989. He holds NJ licenses for Podiatry and for Pharmacy, and is certified by the American Board of Podiatric Orthopedics.

Ned Brann RPh, DPM
Vice President Regulatory Affairs
Mr. Brann brings over 30 years of Regulatory Affairs experience with Glaxo SmithKline and Johnson & Johnson to head APCER Pharmas’ regulatory operations for North America. During his years with Johnson & Johnson, Mr. Brann has provided global and regional strategic regulatory guidance to project teams in multiple therapeutic areas including CNS, anti-infective, haematology, allergy, women’s health, dermatology and cardiovascular. He has directed interactions, including meeting with multiple FDA review divisions and lead teams in the development, critical review, submission and negotiations of multiple NDAs, SNDAs, INDs, and PLAs. He also has experience with 505b2 NDAs. Mr. Brann also represented his department on the core product label review committee for J&J’s pharma sector. This extensive experience includes both large and small molecule products. Mr. Brann received his undergraduate degree in Biological Sciences from the University of Notre Dame and his masters degree from Penn State University with emphasis in biochemistry. He worked as a research biochemist at Glaxo SmithKline before joining their Regulatory Affairs department.

Navita Srinet
Country Head, India
Navita is a Pharmacy graduate from Delhi University with an MBA in Marketing. She has 14 years of sales, marketing and business development experience in the Indian and European pharmaceutical industry. During this time she has worked with companies such as Winthrop, SmithKline Beecham, Ranbaxy and Jubilant Organosys. In her current role at APCER, she has been responsible for setting up the infrastructure and building up the Pharmacovigilance, Regulatory, Contract Manufacturing and Business Development teams in the India office which provides back end support to the North America, Europe and Asia operations.

Ron Lillie
Director, Client Services & Technical
Mr. Ron Lillie is a graduate of the University of Toronto with a B.Sc. majoring in Human Biology and has taken graduate classes including biomedical engineering and statistics, in pursuit of a M.S. degree. He has worked with safety service and software providers, including most notably Relsys, ArisGlobal and Phase Forward in a variety of consulting and product management roles supporting client safety initiatives and pharmacovigilance applications. As a product manager, Ron contributed to the development of signal detection and risk management systems utilizing both in-house and FDA-AERS data as well as wrote specifications for safety data reconciliation. In this capacity he has conducted multiple client-facing activities such as workshops and webinars as well as contributed to drug safety software user groups. Among other training activities conducted over the years, Ron presented a training class in signal detection using the agSignals application to Health Canada in 2008. Ron has been a member of the Drug Information Association since 1990 and has served on the CDM Terminology SAIC for which he has taught MedDRA related classes and has presented at the DIA on other topics such as 21 CFR Part 11.

Dr. Achint Kumar
GM Pharmacovigilance, UK
Dr. Kumar is an MD in Pharmacology who started his career in the pharmaceutical industry at Ranbaxy, where he led a team of Drug Safety Physicians and Research Scientists whose responsibilities included management of ADR cases, PSURs and SOPs, validation of database, causality assessment, review of PSURs and Safety Data Exchange Agreements, signal generation and evaluation, risk management plans and compliance monitoring. In APCER, Achint headed the Pharmacovigilance Unit of the India office, played a decisive role in setting up this unit and guided teams for client and regulatory or competent authority inspections. In his current role Achint manages the Pharmacovigilance function at all levels, leads the Pharmacovigilance team and functions as QPPV for various clients.