Activities & Services


Protective wings on your health



Knowledge and expertise


PhAST Consulting employs a full-time staff of 11 highly qualified professionals and 5 experienced consultants, who, together, will put more than 200 years of experience at your disposal. To ensure we stay abreast of changes in the field we invest heavily in the training and the professional development of all our employees. We also offer the same training to our clients.


PhAST Consulting applies scientific rigor, innovative methods, and industry-leading expertise to perform such activities and ensures a strict adherence to the standard operating procedures of the company, after an adequate training with a continuous availability to their updates. Our experience, gained during many years of consultancy support, guarantees the high quality level of the services provided. Furthermore, to ensure full compliance, our Pharmacovigilance and Regulatory Affairs experts work closely together on all projects.


PhAST Consulting guarantees that all information and documentation will be handled with the utmost confidentiality.


Our experience, gained during many years of consultancy support, and
the continuous training, guarantees the high quality level of the services provided




To spread out your wings safely



Pharmacovigilance during clinical trials


PhAST Consulting can provide the following services, starting with the review of clinical trial protocols, together with the clinical investigators, with regard to the section related to the assessment of the investigational medicinal product safety:

Identification



  • Code breaking procedures if and when required.


Evaluation



  • Adverse events (AEs) and serious adverse events (SAEs) assessed by a qualified medical review.

  • Serious, unexpected, suspected adverse reactions (SUSARs).

  • Request of any missing information to all Clinical Trial Centres involved.

  • Data entry of cases into a validated database.

  • Reconciliation between the clinical database and the pharmacovigilance database


Preparation and Submission



  • Preparation of CIOMS I-form, DSURs and semi-annual SUSARs reports.

  • Integrated clinical and statistical reports.

  • Submission of SAE to the Sponsor and SUSARs to EMA, CAs and Investigators.


PhAST Consulting can support the Sponsor of non-interventional clinical studies with all requested pharmacovigilance activities according to Italian and European rules.



The highest standards of performance




Post-marketing Pharmacovigilance


PhAST Consulting can offer either a complete range of pharmacovigilance activities, including a back-up during Company's closure, or a temporary support according to the Company's need.


The services may include:



  • Covering the need of having an EU QPPV and/or a local contact person (Italian affiliate of International pharmaceutical companies).

  • Maintenance of a local Pharmacovigilance system.

  • Case-processing of all suspected adverse reactions reported directly to company, received by the Authorities or collected from the international scientific literature, and their data entry in validated database.

  • Daily management of the National Pharmacovigilance Network (RNF).

  • Search and review of the local and international literature.

  • Signal detection and Benefit-Risk evaluation.

  • Expedited reporting of cases to the Authorities, AIFA and EMA, when necessary

  • PSURs' planning and preparation.

  • Company support in the ensuing dialogue with the Authorities in order to optimize the replies to the Regulatory Authorities' requests.

  • Review and update of all information regarding the safety of medicinal products, including writing of the related Risk Management Plans.

  • Preparation and maintenance of the Pharmacovigilance System Master File (PSMF).

  • Revision of Pharmacovigilance agreements together with the contractual partners.



Flying towards safe horizons



Medical device surveillance


Since 2009 manufacturers are required to register their class IIa, IIb and III medical devices in Italy. The guidelines on a Medical Devices Vigilance System (MEDDEV v2.12-1 as updated) require immediate reporting of incidents, where immediately is “without any delay that could not be justified”. If the cause of the event is not clear, the manufacturer has time to evaluate if the product was indeed the cause of the event. However, if further events could have been prevented during the evaluation time, then it was not acceptable to delay reporting.


PhAST Consulting can assist the Manufacturer as follows:



  • Global complaint management (medical, technical, commercial, combined complaints), by forwarding the complaints to the competent business functions of the client.

  • Medical complaints processing (adverse effects/incidents) and their management into a validated database.

  • Preparation of incident reports either as per Annex 3 and 4 of the guidelines or with the forms predisposed by the Italian Ministry of Health and their notification to the Competent Authorities.

  • Send urgent communication in the Italian language to the Italian Ministry of Health through certified e-mail.

  • Preparation of the safety exchange agreements with contractual partners.



 



Vigilance of Cosmetics


Article 4.1 of the European Cosmetics Regulation No. 1223/2009 states that Only cosmetic products for which a legal or natural person is designated within the Community as Responsible Person shall be placed on the market.


PhAST Consulting can:



  • Assist the Responsible Person and provide the regulatory requirements regarding compliance of the client"s cosmetic products with the Authorities.

  • Write and update the Product Information File, which the company needs to keep for 10 years after the last batch was removed from the market.

  • Global complaint management (medical, technical, commercial, combined complaints), by forwarding the complaints to the competent business functions of the client.

  • Processing of medical complaints (adverse effects) by entering the cases into a validated database.

  • Send urgent communication in the Italian language to the Italian Ministry of Health through certified e-mail, including the reporting of serious undesirable effects (SUEs).



A watchful eye on the flock



Database (SafetyDrugs® www.safetydrugs.it)


PhAST Consulting uses the cost-effective pharmacovigilance software system (SafetyDrugs®) developed by MaxApplication S.r.l. Italy for processing cases with adverse events to medicinal products, vaccines, medical devices and cosmetics.

SafetyDrugs® is a web based system, powered by Oracle®, that manages the overall pharmacovigilance process: data entry, quality check, medical review, expedited and periodic reporting to Authorities, global analysis of all entered adverse events.


The system is validated and compliant to ICH, EMA and FDA guidelines and supports MedDRA and WHO drug coding. The structure of SafetyDrugs® allows an easy update according to new rules as well as to new pharmacovigilance requirements.


PhAST Consulting provides the company with the data processing into the database, by performing data entry, quality check, medical review of individual case safety reports and by producing reports such as CIOMS I forms / line listings / Summary Tabulations, etc. according to the need of the Company, and gives its support in case of Authorities' inspections.



A broad mission



Preparation and maintenance of a quality system in pharmacovigilance


PhAST Consulting will put more than 200 years of experience at the Client"s disposal to assist with:



  • The preparation and editing of Standard Operating Procedures, Working Instructions and Forms for the conduct of Pharmacovigilance activities (according to the current legislation in Italy/Europe and the EMA/ICH guidelines).

  • Preparation and maintenance of the Pharmacovigilance System Master File (PSMF) with the support of all involved functions of the company.

  • Pharmacovigilance agreements between the Company and their Contractual Partners.

  • Training and refresher training on Pharmacovigilance, new guidelines (Italy, Europe, FDA), and company SOP's.

  • Audits e pre-audits of the company's Pharmacovigilance system.



 



Regulatory Affairs


In Regulatory Affairs there are many new requirements. Readability testing of the Package leaflets has become obligatory for better patient understanding. The deadline for the companies to adhere to this new requirement is July 2015. As the exercise is centred on the creation of a simpler, clearer and easily understandable patient leaflet in the Italian language, to be tested with native speakers, PhAST Consulting deems it of fundamental importance that all aspects of the process are handled by Italian experts. Our clients can rely on our experience to handle all requirements correctly and efficiently, offering value for money in terms of cost and quality of service.


The Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) became mandatory in July 2012. From June 2014 till the end of the year Marketing Authorization Holders are required to update their records. Performing all these updates will significantly increase companies' workloads, not to mention the follow-on maintenance process.


To ensure full compliance, our Pharmacovigilance and Regulatory Affairs experts work closely together on all projects.


PhAST Consulting can assist their clients with:



  • Regulatory preparation and submission

    • Marketing Authorization Applications (DCP, MRP, National Procedures).

    • Variations (Type I – II), Switch from POM to OTC, including publication in the Official Gazette.

    • Marketing Authorization Renewals.



  • Readability testing Package leaflets

    • Editing the text of the leaflet , correcting and simplifying where necessary for easy understanding, and aligning the content with the Quality Review Document (QRD) template.

    • Recruitment of the target group of test readers, as representative of possible future users, balanced for age, gender and education and who are native speakers of the Italian language.

    • Face-to-face interviews with the final 10 subjects of the test.

    • The Outcome Report, ready for submission to the regulatory authorities in CTD Module 1.3.4, to be delivered and discussed with the client before finalization.



  • Technical writing, reviewing and updating

    • Modules 1, 2, 3, 4 and 5 preparation.

    • Reviews and updating of approved dossiers regulatory/quality gap analysis, CTD conversions.

    • Regulatory compliance (GLP, GMP, GVP).



  • Assistance for start-ups, small and/or International companies

    • Legal regulatory and administrative representation of Int. companies operating in Italy.

    • Transfer of the Marketing authorizations.

    • Pricing & Reimbursement activities.

    • Due diligence of pharmaceutical Dossiers

    • Compliance check of artworks for labels and leaflet.

    • Updating and maintenance of the required XEVMPD records.

    • Medical review and signatory for medical information, scientific and promotional materials.





Flying safely towards new environments



Italy, where the market is considered as one of the toughest in all of the EU.


PhAST Consulting may act as a One-Stop Shop for start-ups, small companies or International companies wanting to enter the Italian market, offering assistance with:



  • Specific Business advice and hands-on local support for Regulatory Affairs and Pharmacovigilance.

  • Regulatory legal and administrative representation of International companies operating in Italy.

  • Provisional ownership during registration and transfer of the Marketing authorizations.

  • Pricing & Reimbursement activities.

  • Due diligence of Pharmaceutical dossiers

  • Review market conditions, competitive landscape and patient pool.

  • Medical review and signatory for medical information, scientific and promotional materials.

  • This enables our clients to hit the ground running and concentrate on the commercial issues, while keeping their headcount down.


Outsourcing to local know-how is a cost-effective way to enter the Italian market successfully




Training to Fly


PhAST Consulting invests heavily in the training and the professional development of their employees as it is crucial for everyone involved to stay abreast of the rapid changes in the field, but also offers the same opportunity to their clients' personnel.



  • Basic Pharmacovigilance as required by the Authorities.

    • Target audience: Pharmaceutical sales representatives, all office personnel.



  • Legal, Regulatory and Medical aspects for Medical Reps.

    • Target audience: Pharmaceutical sales representatives.



  • Risk Management Plan.

    • Target audience: Pharmacovigilance and Regulatory teams.



  • Medical Writing

    • Target audience: Pharmacovigilance and Regulatory teams, Physicians and Other Healthcare Professionals.



  • New Guidelines (Pharmacovigilance, Medical devices)

    • Target audience: Pharmacovigilance and Regulatory teams, Client services personnel.



  • Pre- and Post-Marketing Pharmacovigilance (Medical devices).

    • Target audience: Pharmacovigilance and Regulatory teams.