Harten Group

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A generics company headquarted in Ireland is branching into branded pharmaceuticals and requires ongoing help and support in negotiating an entirely new way of working to ensure local and UK Code compliance. One of our consultants became involved with training and raising awareness of the Code and even had to respond to a Code of Practice complaint - completely new territory for the Company - which resulted in a positive outcome. The consultant has subsequently introduced a second team member - an expert in Code compliance - to help with developing SOPs among other activities.

Medical advisers at a US-based company were asked to review and approve documentation relating the company’s procedures for complying with the US Foreign Corrupt Practices Act (FCPA). Concerns were expressed that this was outside UK or EU law and that the indemnity cover might be inadequate. A Harten Group consultant was able to clarify the position, after undertaking research and liaising with a legal firm. He has since been asked to write an authoritative article on the subject and give a 45-minute presentation at a national symposium.

A global pharmaceutical company was instructed to provide monthly safety updates for a marketed antiviral for the duration of the recent flu epidemic. The consultant took over the safety review and signal detection analysis, prepared full sets of tables from the company databases, wrote the monthly reports, and responded to all subsequent queries from regulatory authorities.

A European generics company had received three critical findings at a recent Pharmacovigilance inspection. The CEO believed that commercial operations were at risk if remedial actions were not taken prior to the re-inspection. After radical review, restructuring of operations and essential client training, the repeat inspection passed without any major or critical findings. The inspectors reported they were delighted with the company’s involvement.

Our client, a global pharmaceutical company headquartered in Europe, requested we provide a review of all copy approval practices for a European subsidiary. There had been an infringement of national codes by one subsidiary. A full review showed many areas of poor understanding and miscommunications between Medical Information, Marketing, Sales and Personnel responsible for Medical Certification. Our recommendations were accepted in full and one of our team was recruited full-time to lead the Marketing Code Compliance unit.

A pan-European Reimbursement and Pricing review was required by a US client. France, Germany, Italy, Spain and UK were targeted. Over 40 face-to-face interviews were conducted across Europe. Details of policy and practical details of how they were enacted in one particular therapeutic area were discovered. Country-country as well as in-country variation were highlighted. Marketing teams within the client were surprised by the high level of detail discovered. The results are being used to inform pricing strategy across Europe.

Conflicting advice had been given by a European Regulations Agency. Additionally a product had received marketing approval in Australia and it was questioned whether this would persuade European regulators to grant a licence in the EU. A contractor was sourced and provided with deep experience of this type of dilemma, having worked in appropriate regulatory agencies. Concise, pragmatic opinion was given enabling decision-making by senior management.