PVCON

MOIN DON

President & CEO

Moin has over 33 years experience in the pharmaceutical industry.

Pharmacist by education, Moin is one of the most well known 'Pharmacovigilance Professionals' in India.

He has rich hands on experience of practically every facet of Industrial Pharmacovigilance, while serving reputed international pharmacos like Sanofi Aventis & his last assignment being, with Johnson & Johnson as Regional PV QA Director for Asia Pacific. Moin has undergone extensive training in U.S, Germany, France & Singapore and is a certified 'Lead Auditor'.

He is one of the co-author in developing the protocol for 'India's National Pharmacovigilance Programs. In addition Moin is also a member of the Central Advisory Committee of DIA India. He is a visiting faculty & international speaker & author whose articles have been published in international journals of repute.

RAMEEZ DONSenior Consultant

Rameez Don is Certified Lead Auditor & Consultant with around 10 years of professional experience across diverse fields like Pharmacovigilance, Quality Assurance, Audits, Training, Business Development, Operations, Staffing & Human resources. Rameez heads Business Operations and Training divisions at PVCON. He is also actively involved in the Quality Assurance and PV Auditing segment of PVCON. Prior to joining PVCON, he spent around 8 years with Cognizant handling diverse lead roles in Operations, Staffing and Quality Assurance.

Rameez is currently pursuing his PhD in Pharmaceutical Management and has completed his M.B.A and PG Diploma in Pharmacovigilance from Bombay College of Pharmacy.

He is passionate about Training and actively involved in Career & Personal Counselling initiatives.

SONAM GARGSenior Consultant

Sonam is Senior Consultant with PVCON and has over 5 years experience as GCP auditor & Documentation Specialist.

Sonam has been involved in activities pertaining to quality assurance in clinical research besides PVQA as part of her consultancy ventures since 2008. She freelances providing institutional and corporate training, conducts audits and assists professionals by providing continuous quality support for various projects.

She has conducted Investigator Site & CRO audits, handling various aspects of audit conduct. She has worked with a London-based QA firm for 2 years managing international GXP projects, authoring SOPs and other quality documents. She has also developed processes and other training materials for consultants, academia and pharma clients.

She is a visiting faculty at Academy For Clinical Excellence, Maharashtra University of Health Sciences (KEM) & St. Xavier's College, Mumbai.

Nazrul KhanOur EU-Africa Network

Nazrul Islam Khan, Director of GPVQA, based in the UK, has up to 14 years of PV operational and PV auditing experience, working both within the United Kingdom (UK) Regulatory Authority (Medicines and Healthcare Products Agency (MHRA) and small to large global pharmaceutical companies (recent assignment includes Janssen Pharmaceuticals, a Johnson & Johnson Company). He is also a member of the Research Quality Assurance (RQA) GPvP Committee, co-author of the RQA PV Auditing Handbook, and a tutor on the popular RQA Practical PV Auditing Course.

Subject matter expertise and experience includes the following areas (but not limited to):

• Quality assurance auditing in all PV audits types as well as GCP and GDP systems
• Development and implementation of PV quality management systems
• Risk-based audit program design, development and implementation
• PV operational expertise and experience in adverse event case handling (from all sources), signal detection methodologies, risk management plans, risk evaluation and mitigation strategies, periodic safety update reports, medical information handling, product quality compliant handling, safety variations, MedDRA coding and implementation, safety database validation, post-authorisation safety studies design and setup, management of structured data collection programs (solicited non-interventional initiatives), and pharmacoepidemiology

Catarina MacedoOur EU Network

Catarina Macedo has over 12 year's experience within Pharmaceutical Research & Development (R&D), Post-Authorisation Pharmacovigilance (PV), PV Quality Assurance (QA) and PV Quality Management Systems (QMS). Pharmacist by education, Catarina started her professional career at the Portuguese Competent Authority (Infarmed) in the Health Products Division. In 2002 she joined the European Medicines Agency PV Sector where she worked in the implementation of the EudraVigilance System including production of the training materials and teaching the EudraVigilance System DIA train the trainer sessions. At the EMA, Catarina was also a key contributor to the development of the EudraVigilance Medicinal Product Dictionary, participated in signal detection activities and handled scientific linguistic reviews of product information for centrally authorised products.

Since 2004 Catarina has held a number of PV roles within the pharmaceutical industry and PV service providers in an international setting. These have included Novartis Global Clinical Trial Safety Operations in the UK, Cancer Research UK, Vigilex, United Biosource Corporation. In 2012, Catarina became a freelance pharmacovigilance professional based in Geneva (Switzerland) where she lives and works.

Catarina Macedo has experience in full PV system set up including implementation of safety databases, development and maintenance of PV QMS and PV QA activities such as PV audits, performing mock inspections, providing inspection readiness training / support and performing gap analysis. With a strong PV operational background Catarina has extensive practical experience in case processing; safety reporting; signal detection; literature reviews; aggregate report scheduling and production; risk management plans production and maintenance; safety related regulatory activities; and PV training. Catarina lectures a course in Risk Management in Clinical Trials as part of a post-graduate diploma at Universidade Lusofona in Lisbon and has been a trainer and speaker on PV topics at the DIA, National Cancer Research Institute (UK), the Drug Safety Research Unit (UK), the Oncology Clinical Trials Office (OCTO in the UK) and other international conferences.