Pharma Design can help you to prepare for Regulatory Inspections by carrying out a pharmacovigilance audit to ensure you have covered all aspects in this area. Pharma Design can carry out such audits at any level of your organisation and our pharmaceutical consultants will suggest corrective processes you need to take if required. We can also arrange follow up audits to ensure you have put these corrective procedures into practice properly.
Auditing (PVG, GCP, GMP, GDP)
Pharma Design provides audits of pharmacovigilance systems involving a variety of other functions within the organisation. With years of auditing experience, Pharma Design can produce an auditing plan for your company, your affiliates, your Vendors and Marketing Partners, tailored to your specific needs and requirements. We can also provide Good Clinical Practice (GCP) audits of clinical sites and CROs.
These pharmacovigilance audits have become increasingly rigorous and by us completing an audit, we can help you to avoid costly mistakes and restrictions from regulatory inspectors. Pharma Design can also provide third party audits (i.e service providers, vendors, clinical sites) on behalf of the client. Thanks to our long term experience with MHRA inspections, we can anticipate major and critical findings in most cases.
Training of internal personnel
Pharma Design can deliver general or in depth training to your internal personnel on pharmacovigilance, ICH guidelines and EU regulations. We create a bespoke training programme tailored specially for your pharmaceutical products and the level of complexity required. Our training courses are like no other, we give you our expert knowledge and information whilst keeping a hands on and informal approach.
Pharma Design can assist your company further by providing inspection and auditing training to ensure you are fully aware of all necessary regulations.
Training of Investigators and CRAs
Training of investigators and CRAs is critical and it is an essential part of hanving a successful GCP audit. Besides from a GCP inspection perspective, it enhances the quality of the data from studies and helps promote the value of your products from the very beginning.
Pharma Design offers efficient on-site training to investigators, clinical site personnel and CRAs. Once again, the training is tailored to the individual study compound and the level of complexity required by the recipient.
If you or your company needs advice and assistance with pharmacovigilance training or audits, call +44(0)20 3875 4111 or +353 (0)1 902 0049 or fill in our enquiry form and one of our pharmaceutical consultants will be in touch within 24 hours.