Pharmacovigilance

Bio Chem Srl provides direct consulting activities to carry out all the activities required by current rules on pharmacovigilance, carrying out the activity according to the dictates of the Italian law N° 219 of 24/04/2006 published in the Official Gazette N ° 142 of 21/06/2006, and, especially, according to art.131 dictates of that law and subsequent amendments and additions, imposed with the entry into force from July 2012 new rules on pharmacovigilance (1235 Regulations December 2010-Directive N ° 84/2010).

By way of example, our services include:
- Assumption of responsibility of local QPPV (eu-QPPV in case of Italian companies) or QPPV deputy or availability in case of absence of QPPV;
- Reception / evaluation of adrs (adverse drug reactions) reporting and in line with regulations;
- Access to the national pharmacovigilance network;
- MedDRA Registration;
- EudraVigilance registration and data inserting on behalf of the client (ICSRs and XEVMPD data);
- Preparation of periodic safety update reports (PSURs), SOPs and Working Instruction support;
- literature search;
- Adverse Events clinical Evaluation and related Scientific Literature;
- Descriptive documents for the pharmacovigilance systems (Pharmacovigilance system master file, risk management plan) preparation;
- Trade agreements of safety data (Safety data exchange agreements) preparation;
- Internal audits, preparation to inspections of regulatory authorities;
- Pharmacovigilance training;
- One to one educational programs;
- Group educational programs;

PHARMACOVIGILANCE Quality assurance

The new legislation and specifically the Article 8/9 of the Executive Regulation 520/2012 lays down the minimum quality requirements for the conduct of pharmacovigilance activities.
Bio Chem Srl, certified ISO 9001/2008 for regulatory services, provides QA services pharmacovigilance process management and pharmacovigilance activities in order to ensure an adequate and active quality system, monitoring and evaluating the effectiveness of the structures and of established processes implemented by the company, also offering the possibility of customized training courses for companies, in order to assure the compliance with existing regulations.

NEWS - BIO CHEM S.R.L.


COURSES

Our company offers courses from different content for different sectors.

REGULATIONS

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LOCATIONS

View all Bio Chem Srl headquarters in Naples, Rome, Milan


NEWSLETTER

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SURVEY

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LINK PARTNER

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