Regulatory and Product Liability
Pharmaceuticals are undoubtedly the most regulated industry sector and devices could arguably be moving in the same direction.
An in-depth understanding of the restraints imposed by national and international legislation is vital in ensuring that commercial strategy and agreements are going to be workable.
During the research phase we are asked to advise on legal and ethical issues in clinical trials in relation to subjects, investigators, study sites and ethics committees.
Pre-marketing, our assistance is commonly sought in testing or challenging a position taken by the applicant or competent authority.
Post-marketing issues upon which we are asked to advise include labelling, advertising, vigilance and supply. In addition pricing and reimbursement issues are playing an increasing role with the development of 'fourth hurdles'.
Specifically the life sciences group has assisted clients in the following situations:
Research
- Contractual arrangements with investigators and institutions including negotiations over subject indemnity and publication rights
- Advising on GLP, GCP for sponsors and monitors and GMP issues
- Patient and healthy volunteer consent and compensation issues
- Data confidentiality and transfer
Unlicensed Products
- Compassionate use matters
- Non-sponsored experimental use of unlicensed medicines and off-label trials
- Unlicensed medicine supply
- Orphan status products
Obtaining Approval
- General dealings with Health Canada and the European Medicines Agency, the CPMP, CVMP, the medicines, devices and borderline functions of the MHRA and the VMD
- Device classification and dealings with notified bodies
- Electronic submissions and related security issues
- Establishment requirements
- GMP, qualified person and batch release
Post-Marketing Authorisation
- Negotiations and representation with other companies and the regulatory authorities on advertising compliance and inter-company disputes
- Pharmacovigilance and device vigilance and related safety, regulatory and liability issues
- Website review
- Direct to consumer information
- Labelling and package insert compliance and product liability exposure
- 'Data exclusivity' - Generic applications and bibliographic applications and challenges thereto
- Reimbursement and pricing advice and representation
- Data confidentiality and data transfer
Borderlines
- Advice and competent authority negotiation on the drug/device, drug/food, drug/cosmetic, device/cosmetic borderlines
- The conduct of judicial review proceedings against product status determinations
- Advice to nutritional, herbal and homeopathic producers on claims and permitted constituents
- Advice in relation to delivery systems and devices incorporating medicines under the drug/device borderline
Medical Devices
- Device categorisation
- Drug/device borderline challenges and disputes
- Obligations of manufacturers and authorised representatives under the device directives
- Device labelling
- Device vigilance
Product Liability
- In the event that an allegation is made that a product is involved in a personal injury or death it is vital that the corporation has access to advisers who understand and are familiar with the legal processes for either individual or multi-party claims and the regulatory, public affairs and insurance dimensions of such a claim
Selected Experience
Publications
Events
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