Regulatory and Compliance

EXPERIENCE

Clinical Trials and Investigations

• Advising on requirements for approval of clinical trials by ethics committees and competent authorities
• Advising on all aspects of transparency and data privacy of trial data
• Drafting and negotiation of clinical trial, principal investigator and research development for collaboration agreements or multi-centre trials

Authorisation and life cycle management

• Advising on issues related to post-marketing vigilance activities including adverse event reporting and product recalls
• Assisting in the establishment of regulatory pathways to market medicinal products, combination products, medical devices and borderline products
• Assisting clients with challenges to decisions by the Irish Health Products Regulatory Authority (HPRA) and the National Standards Authority of Ireland (NSAI) concerning the classification, regulation and promotion of products, as well as the Department of Health and Agriculture and the Health Service Executive (HSE) with regard to pricing
• Advising on EU orphan drug designation, data and market exclusivity and supplementary protection certificates
• Preparing and reviewing supply, distribution, manufacturing, packaging and pharmacovigilance agreements

Compliance with anti-bribery and transparency requirements

• Assisting in negotiating and drafting agreements with physicians and other healthcare professionals
• Advising clients on hospitality arrangements and gifts provided to healthcare professionals
• Providing advice in relation to transparency requirements, including disclosure of transfers of value and other benefits to healthcare professionals and healthcare organisations

Promotion and marketing

• Advising on advertising and promotion of products, including experience as a member of the promotional review team of a global pharma company
• Assisting in developing EU-wide and Irish-specific promotional and marketing policies
• Advising on development of product-related and disease awareness websites with regard to EU and Irish rules on marketing of medicinal products