On its private
level, the European Pharmaceutical Law Group
is a consultancy firm specialising in the pharmaceutical sector. Its team of professionals is primarily made up of practising lawyers, although it also receives the support of scientific experts (project development) and its public relations department (media relations, information and training). Eupharlaw also works on the basis of the requirements of each individual case, training specific multidisciplinary groups of professionals for each project from among its 100 or more collaborators and participants.
For this reason, our team is generally able to provide its clients with legal advice in connection with consultations or dispute resolution, corporate or institutional management or mediation, arbitration and conciliation services within the area of pharmaceutical law.
Likewise, we have a proven track record in the structuring and management of working groups, the publication of specialist monographs, and the coordination
of training courses of great interest for the pharmaceutical industry and professionals, as well as the general public as a whole.
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Therapeutic Information
*
Therapeutic Information Direct to the Citizen
*
Therapeutic Information in the media / via Internet
*
Therapeutic Information vs. advertising
*
Direct on-line and multimedia project implementation
*
Product defect liability
*
Liability for misinformation
Scientific
Research
* Research: clinical trials
and post-marketing research
* Approval: registrations, prices, autorisations and and
licences
* Manufacturing and distribution: specialists in labelling,
product packaging materials and patient information leaflets
* Marketing and distribution: market research and marketing
support
* Pharmacovigilance
* Prescriptions
* Dispensing / Pharmaceutical care
* Use of medicines / Compliance
*
Design, start-up, monitoring, coordination, statistical reports
and reporting of results of Clinical Trials
Business
Management
* Intellectual
Property
* Parallel Imports and Exports
* Data File Protection
* Mergers and Acquisitions
* Licence Agreements
* Distribution Agreements
* Co-marketing Agreements
* Cooperation and Co-development Agreements
* Agency Agreements
* New Technology and Technology Transfer Agreements
* Public Procurement and Tender Agreements
* Environmental Standards
* Civil Liability Insurance
Food Safety
Due to the ever closer
relationship between the pharmaceutical and food
sector, we must now meet the needs of our clients
in this area, advising them on the following matters:
*
Processing of product registrations with the Ministry of Health
*
Notices of new product placements
*
Advice on advertising promotions for commercial purposes
* Procedures for differentiating between information
and advertising
* The right to receive information on food safety
* Information on food safety and liability
*
Design, start-up, follow-up, co-ordination, statistical reports and reporting of results of clinical/scientific trials
Data
Protection
Personal
data protection on heath matters related to:
* Clinical Trials and the submission of dossiers
* Prescriptions
* Dispensing/ Pharmaceutical Care
* Distribution
* Therapeutic Information Direct to the Citizen and data collection
* Biotecnology, Assisted Reproduction and Genetic Information
* International Data Transfers
* Data protection in mergers and acquisitions
* Confidentiality agreements
* Data transfer agreements
* Data purchase agreements
*
Service agreements
* Contracting and electronic communications
* Information security and computer fraud
* Data protection strategies