Subject Matter Experts
John DR Jolley - FR Pharm S, FCQI CQP RSC
Is a Pharmaceutical Consultant providing technical consultancy and bespoke training solutions to SME’s and Organisations operating in emerging markets, he has a degree in Pharmacy and has been awarded fellowships with the Royal Pharmaceutical Society and Chartered Quality Institute.
He has held positions in; Clinical Research, Product Registration, Manufacturing, Quality Assurance, and General Management. He was Technical Director for Boehringer Ingelheim UK for 15 years before coming to working on International consultancy and is a practicing Qualified Person (QP) with experience if working in sterile product manufacture and clinical trials.
David Cockburn BSc (Hons)
David is a very experienced manufacturing quality compliance professional, with a grounding in both the pharmaceutical industry and the regulatory authorities at national and EU level. He also had considerable international exposure.
After 5 years in the pharmaceutical industry, which included 4 years as a section head managing the production of a variety of different sterile and non-sterile dose forms at Glaxo Operations in the UK, David became a GMP inspector for the UK authority now known as MHRA. Over a period of 14 years David conducted many GMP inspections in the UK and overseas as well as GDP inspections within the UK. Latterly he held a senior role and was involved in coaching and training and took a specialised interest in small-scale manufacture with particular focus on Investigational Medicinal Products (IMPs). He was also involved in the establishment of the GCP inspectorate and the development of related inspection processes.
David worked for the European Medicines Agency (EMA) for 15 years and was head of the Manufacturing and Quality Compliance Service with, among other things, responsibility for GMP inspection coordination, managing of quality defects with centralised products and working with EDQM on the sampling and testing of centralised products. He also held the chair of the GMP/GDP Inspectors Working Group which provides expert input on the development of EU GMP for the European Commission and develops harmonised inspection standards and procedures for GMP inspectorates of the EU National Competent Authorities.
Prior to leaving EMA David was the EU technical lead working with US-FDA on mutual reliance in GMP inspections culminating in the signing of the EU-USA Mutual Recognition Agreement in 2017.
Although EU is not party to APEC, the Asia Pacific Economic Cooperation forum, David was the GMP work stream lead lead for the APEC Global Product Integrity and Supply Chain Security Roadmap project.
David has a degree in Pharmacy from Robert Gordon’s Institute of Technology, Aberdeen (now the Robert Gordon University). He is eligible as a Qualified Person within the meaning of art. 43 of Directive 2001/83/EC.
David served as an expert for EU on the ICH Q8, Q9 and Q10 Implementation Working Group 2008-2011 and was also EU’s deputy topic leader for ICH Q12 (Lifecycle Management) between 2014 and 2016.
He was awarded a recognition plaque by the Parenteral Drug Association (PDA) in 2012 for promotion of pharmaceutical quality and regulatory communication.
Mr Steve Jolley, CEO of SJ PharmaConsulting LLC
Steve Jolley, CEO of SJ Pharma, has more than two decades of experience in drug safety and pharmacovigilance. Throughout his years in the industry, he has worked with over 100 clients in the US, Europe, Japan, India and China. Steve is an Adjunct Professor at Rutgers University and teaches part of their Master's degree in Drug Safety and Pharmacovigilance. Steve is also a member of the Drug Information Association’s training faculty and an instructor for the DIA’s Clinical Safety and Pharmacovigilance Certificate Program. In 2010, Steve was elected as chairman of the DIA’s Clinical Safety and Pharmacovigilance steering committee for North America.
SJ Pharma offers a variety of drug safety and pharmacovigilance online training courses. Each module is fully interactive, and will take you 3 to 4 hours to complete. At the end of each module is an exam which you can retake if needed. Once you achieve a passing grade you will receive a certificate for that module.
Steve is Adjunct Professor, Rutgers University , has over 28 years' experience in drug safety & pharmacovigilance and is a Specialist in global safety compliance, business process improvement and signal detection having Worked with over 100 clients in the US, Europe, Japan, India, and China.
He is an International speaker on drug safety compliance and signal detection; invited to participate at events in North America, Europe, Japan, China, India by FDA, EMA, MHRA, Chinese SFDA, Health Canada, DIA where he is Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America.
Steve has Degrees in mathematics and computer science from Cambridge University, England.
Lisa Bissett, B.Sc. Director, Regulatory, CMC – PharmaConsult Global
Lisa Bissett an experienced Regulatory Affairs professional with more than 20 years of experience in the pharmaceutical industry, specialising in CMC aspects of Regulatory Affairs.
Lisa has proven leadership and communication skills with a robust individual reliability and a demonstrated track record in delivering diverse projects. She has a wide experience in regulatory affairs, from the initial licensing process, throughout the life cycle of the product to enhance product value and in maintaining compliance.
Lisa has an extensive CMC writing expertise in pharmaceuticals and biologicals together with experience of the EU centralised procedure, European national procedures, scientific advice meetings, paediatric investigation plan (PIP) applications and EU clinical trial applications. She is experienced in a wide variety of pharmaceutical forms (including tablets, capsules, oral solutions, creams, sterile injectables, vaccines, freeze dried powders, suppositories and controlled drugs). She is also well acquainted with the UK Home Office Controlled Drugs legislation and Responsible Person requirements.
In her previous roles Lisa has managed various regulatory activities including all types of variations (compilation of supporting data, filing, approval for centralised and UK nationally-approved products), provision of CMC and supporting data to support clinical trial applications and liaison with the contract manufacturing sites for routine issues (e.g. ongoing stability data review, planned manufacturing changes, Annual Product Quality Reviews etc.) She has prepared, coordinated and filed Scientific Advice meeting requests to a number of EU regulatory authorities and supported progression of Paediatric Investigation Plan application to approval by EMA. She has also provided support for various QA activities e.g. routine SOP review, participation in MHRA- and FDA-led cGMP inspections and organised pharmacovigilance/medical information activities.
Lisa has held various roles in regulatory affairs with LB Regulatory Services Limited, Auralis Ltd / ViroPharma Ltd, Medeva/ Powderject/ Chiron/ Novartis Vaccines and Boots Pharmaceuticals/Knoll Pharma AG.
Lisa holds a B.Sc. in Biological Sciences from the University of Leicester and is based in the United Kingdom.
Shashi Patel Director, Solopharm Consultancy Ltd. BPharm(Hons) MRPhramS. QP
Pharmacist qualified from Chelsea College, London. Worked in retail and hospital pharmacy thereafter in UK and Saudi Arabia before moving into industry. During that time also did some lecture tours in India presenting best practices in compounding of parenteral drug products and safe practices in aseptic work. Also contributed to several articles in the Pharmaceutical Journal and the Cytotoxic Handbook.
First industrial post was with Baxter Healthcare Australia gaining vast experience in manufacture of parenteral products and operation of a compounding unit.
On returning to UK became principle pharmacist in running manufacturing unit of hospital which was also a commercial compounding unit. Having become a QP during this period left to join a pharmaceutical company. After 7 years with them following their re-location became a self-employed contract QP and RP to small and large companies. Still operating as a Consultant to the Pharmaceutical Industry 10 years on.
Having being involved with different types of organisation as either QP or RP have extensive experience in GMP and GDP. These roles have involved auditing a variety of establishments i.e. laboratories, manufacturing sites for API’s finished products and storage sites.
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