PHAME’s Discussion Event for Pharmacovigilance and Regulatory Affairs
In April, PHAME held a discussion event for pharmacovigilance and regulatory affairs specialists.
Pharmacovigilance and Regulatory Consultancy for Medical Device and Pharmaceutical Developers
P.O. Box 6,
FI- 02601 ESPOO,
Finland
PHAME offers a wide range of pharmacovigilance services; good distribution practice (GDP), good manufacturing practice (GMP) and good pharmacovigilance practice (GVP) audits; regulatory affairs (RA) services and medical affairs to pharmaceutical and medical device developers.
A unit of Biocodex Nordics, it provides in-depth consultancy services for a wide range of good practice (GxP) requirements, including quality management support, auditing and training.
The firm also offers quick and flexible medical translation services in a wide range of languages.
PHAME helps pharmaceutical and medical device manufacturers to ensure products meet the requirements of pharmacovigilance legislation through efficient analysis, reporting and consultation. In addition, the firm also designs and optimises quality management (QMS) systems.
The company maintains the client’s pharmacovigilance systems throughout the entire product lifecycle as a qualified person for pharmacovigilance (QPPV), local drug safety officer (LDSO) and medical adviser.
PHAME provides high-quality case management services to ensure product safety information is processed efficiently.
The firm’s skilled managers conduct a medical risk-benefit evaluation, archive documents and maintain the product safety register, including the Medical Dictionary for Regulatory Activities (MedDRA). Literature surveillance and review is also available for internationally published materials.
PHAME also compiles and maintains medical documentation such as pharmacovigilance system master files (PSMF), periodic safety update reports (PSUR), risk management plans (RMP) and clinical overviews.
PHAME creates thorough plans for pharmacovigilance quality systems, featuring PSMFs and standard operating procedures (SOP).
It also prepares preliminary internal audits to ensure these plans are implemented effectively to meet GVP requirements.
PHAME’s industry experts conduct advanced training courses such as orientations for registration tasks and guidance on meeting good distribution practice (GDP), good manufacturing practice (GMP), or both.
Pharmacovigilance training is also available, along with guidelines for quality indicators and monitoring compliance.
PHAME offers a number of eudravigilance services to ensure a client’s product data is maintained.
The company helps register products to the European Medicines Agency (EMA) electronic database and the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
The firm also handles electronic transmissions of individual case safety reports (E2B).
PHAME assists medical device and pharmaceuticals manufacturers with regulatory submissions.
The firm provides an expert and dependable service, handling a wide range of submission documentation, as well as providing guidance and expertise on the registration process.
Complete lifecycle management covering:
PHAME has a range of medical affairs services, including:
PHAME’s range of medical device solutions helps support clients throughout the whole lifecycle, from development, to production, registration and distribution. Its services include:
PHAME provides support to clients’ QMSs, demonstrating an extensive knowledge of ISO 9001, ISO 13485, GDP and GMP requirements, as well as standards for wholesale. These high-quality consultation services analyse the effectiveness of internal checks, as well as update or design new processes where needed.
The company’s experienced auditors perform pharmaceutical wholesaler and manufacturer audits, as well as registration, pharmacovigilance and mock audits to help clients prepare for official audits.
In April, PHAME held a discussion event for pharmacovigilance and regulatory affairs specialists.
PHAME organises tailor-made expert training following topics such as good distribution practices (GDP), good manufacturing practices (GMP) and pharmacovigilance.
P.O. Box 6
FI- 02601 ESPOO
Finland