The ACI today welcomes five new hires to bolster our Regulatory and Compliance Unit. The unit, headed up by Dr Parveen Bhatarah, provides regulatory and compliance support to members of The ACI.
Having a validated novel foods application for CBD products became a high priority for companies in the CBD supply chain since the FSA set a deadline for all companies to have these by 31st March 2021. Should they fail to get this validation their products will no longer be legal to sell in the UK.
The larger team will enable The ACI to offer additional services. These are detailed below.
Regulatory clarification
The Regulatory and Compliance Unit provides a critical bridge between our members and the key regulatory bodies in the UK and Europe, whom we are in close and constant contact with.
Compliance support
With over 60 years of combined experience in the regulatory environment The ACI’s Regulatory and Compliance Team are ideally positioned to provide our members with the expertise, practical help and support they need to meet new and emerging regulatory compliance.
They can provide a thorough gap analysis of our members’ situation giving them a detailed checklist of any area where their business can be improved. With this information our members maximise their chances of gaining the full legal compliance required to keep their products on the market.
Bespoke novel food application consultancy
The ACI’s Regulatory and Compliance Unit can offer assistance in preparing, the now obligatory, novel foods scientific dossiers for each of our members’ products. This way they can be confident that their novel foods applications cover everything required to gain the status of “novel foods validation” before the FSA’s 31st March 2021 deadline.
Regulatory Compliance Unit team
Dr Parveen Bhatarah, Regulatory and Compliance Unit Lead
Parveen has over 20 years experience in Pharmaceutical Innovation and international pharmaceutical regulatory experience (MHRA, TGA, ANVISA, EMA, Asia, and Chinese Health authorities). Moreover, Parveen has 12 years experience in the Medicinal Cannabis industry, covering everything from medicinal cultivation to FDA approval of finished products.
Dr Paul Duffy, Toxicologist
Over 30 years toxicology/safety evaluation experience in the pharmaceutical industry (ICI, Zeneca, Astra Zeneca) over a wide range of therapeutic areas including cancer, inflammation, pain, infection, neuropsychopharmacological therapies. Responsible for the non-clinical safety programmes of potential new therapeutic agent development from discovery to drug registration across global territories including US/Canada, Europe, Japan and China.
A European Registered Toxicologist (ERT), a founding member of the In Vitro Toxicology Society and has served on committees of US Society of Toxicology and British Toxicology Society and is a Fellow of the BTS and a Fellow of the Royal Society of Biology. In 2015 Paul became an independent consultant and Associate of ApconiX Ltd with whom he is senior project toxicologist with particular experience in neuropsychopharmacology related therapeutics.
Penny Schenkel, Senior Regulatory and Compliance Assistant
Penny ran her own regulatory consultancy before joining the Resolution Chemicals team in 2017. Penny has held various regulatory roles in the generic and branded pharmaceutical industry and has accrued over 20 years of experience in pharmaceutical development, technology transfer and manufacture for European MAA applications. She has worked efficiently with multiple regulatory agencies across Europe and most recently focussing on the UK market.
Isabel Alber, Regulatory and Compliance Assistant
Isabel is a Food Scientist with 25 years experience in the Food Industry in all sectors and continents. She specialises in Food Safety and Quality Management Systems [ISO 9001, FSSC 22000, BRC, IFS], both in certification as an international third party auditor and as a Consultant in the UK and Europe, helping companies implement international standards and retailer’s codes of practice.
She has broad experience delivering training courses for both Third Party lead auditors and the implementation of Food Safety and Quality Systems.
Dr Sophie Millar, Regulatory Data Assistant
During her PhD, Sophie worked on a variety of cannabinoid related projects, in particular on the clinical use of cannabidiol (CBD), and its pharmacokinetic properties. She has since moved into the health policy arena after spending some time with the research services of the European Parliament, followed by joining the health systems and strategy team at EFPIA (European Federation of Pharmaceutical Industries and Associations). She has been providing consultancy services for a variety of organisations and companies in the field of cannabis and cannabis-based medicinal products (CBMPs) since 2017, ranging from toxicology assessments to evidence database compilation.
Nicole Stone, Regulatory Data Assistant
Currently in her final year of doctorate study, Nicole has a range of experience including phytocannabinoid pharmacology, blood-brain barrier physiology and neurodegeneration. Nicole has worked on various projects in the field of cannabis research and was the 2019 winner of the pre-Doctoral Presentation Award at the International Cannabinoid Research society (ICRS), where she has presented her pioneering research over the past 3 years. During the course of her PhD she has published two first author papers, and has a further two second author papers to her name pertaining to cannabinoid research. Furthermore, Nicole has significant experience in the pharmaceutical industry, particularly regarding ADME studies, DDIs and bioanalytical science.
