Pharmacovigilance Case Studies
Regulatory Case Studies
Supported South Korean Biosimilar Giant with PV/RA Function in EU
RegPak was hired via a well-established multinational consulting giant to support their biosimilar client to provide EU QPPV services for 9 months. During the tenure of RegPak’s EU QPPV, MHRA Inspection took place whereby the EU QPPV provided support in various areas prior to and after the inspection. RegPak’s EU QPPV, guided the company at every step prior to the Inspection to ensure that the Inspection is smooth. Due to constant support provided by EU QPPV during this period, the company decided to delegate the EU QPPV & Deputy EU QPPV function to RegPak in place of the consulting company. RegPak has also been delegated the responsibility of Local QPPV function, Local Literature, Med Info and Product Recall in Ireland. In addition, RA support on drug-device combination for one of the S.C. formulation and data required, incl. all the distribution related variations were submitted upon consultation with RegPak's Founder who is also an expert on RA (biosimilar) matters.
Medical Device Investigation in France and Spain
A small Spanish medical device company wanted to initiate their first medical device investigation in France and Spain. However, the company was unaware of the medical device clinical investigational requirements. Being a European Commission-funded project, this project is crucial for the Client and RegPak. After successful completion of this program, the company intends that RegPak continues to support other studies too including CE marking of the current device for marketing in the future.
Creating a drug safety infrastructure from the ground up
RegPak was hired to establish a drug safety department for a Dutch Vaccine manufacturing company, which had no internal infrastructure to support a safety database, regulatory reporting or experienced staff. RegPak assisted the company to purchase the relevant PV software, configured, and validated a safety database, developed SOPs for this company to function and meet all international and domestic regulatory obligations as well as training the company wide staff on PV reporting requirements. In addition RegPak assisted the company in hiring PV staff, coaching and mentoring the personnel. RegPak continued to work with this company for 3 years until their own in-house PV became fully functional.
Approval of Opiate Containing MP
A major pharmaceutical company, based in Europe, faced a challenge in seeking approval of medicinal product containing controlled DS. RegPak BioPharma prepared the dossier for the Agency dealing with Controlled Drugs to seek approval prior to gaining regulatory approval. The work was delivered within a short time to the client, following which the responsibility of MAA submission was given to RegPak BioPharma.
Proactive signal detection
RegPak was providing routine pharmacovigilance to a big pharma client from India. A specific product had no black box, no Risk Evaluation and Mitigation Strategy (REMS). Signal detection was not warranted for this product thus no formal signal detection program was implemented for this product. During the preparation of Risk Management Plan for a renewal application for this product, RegPak PV expert conducted local literature search. Search revealed an important safety signal having potential impact for the patients. This risk was brought to the attention of clients medical director. As a result, that risk were deemed to be a true signal and resulted in a label change. It was decided that such an important risk must be included in the RMP as a potential risk. The client continued to seek RegPak’s expertise on PV matters and engaged to train newly hired PV team in India.
European Submission for Product Manufactured in China
A major Pharmaceutical company, based in India, faced a challenge in review and update of a Module 3 and Quality Overall Summary for a Biosimilar product (mAb) in preparation for a European submission. The product was going to be manufactured in China, thus GMP compliance was another issue to be looked into. The product was planned to be submitted via the Centralised procedure according to stringent Company deadlines, prior to which a pre-submission meeting was planned with the EMA. RegPak consultant reviewed and updated the submission documents and provided a corrective action list for the manufacturing site. The client reviewed the Site Master File and suggested the pre-submission activities to be performed.
EU Local QPPVs & Literature monitoring
For a large UK based company, Local QPPV services were requested from RegPak. RegPak reached out to its PV network to cover AT, BE, DK & NL to provide LQPVP & local literature monitoring services. Considering efficient process and lower costs, client extended the services to cover HR, SE, NO, FI, CY, PL, RO and PT. RegPak was also recommended to another company by the MAH to cover LV, ES & EE for the related services..
Gene Therapy Company
A well-known company based in Germany and Switzerland required immediate assistance with a global update to the labeling due to new manufacturing sites and changes to core safety information. RegPak consultant with experience in global labeling compliance and CCDS took over this project. The project was staggered by market factors such as the number of language requirements for any one region or market. As with most projects of this kind, other issues were identified e.g., outdated package inserts being used, labels having outdated excipients listed, etc. .
PV-QMS set-up
RegPak was hired to fix the loopholes for a Canadian/Dutch companies that acquired matured products. The company did not have internal infrastructure to support PV function whereby they were marketing in 36 countries. RegPak assisted the company by establishing PV-QMS, auditing distributors in all regions, interaction with service providers, setting SOPs in-house. After successful establishment of PV function, RegPak made an exit following company acquisition.
Global Update for Labeling due to
New Core Safety Information
A well-known company based in Germany and Switzerland required immediate assistance with a global update to the labeling due to new manufacturing sites and changes to core safety information. RegPak consultant with experience in global labeling compliance and CCDS took over this project. The project was staggered by market factors such as the number of language requirements for any one region or market. As with most projects of this kind, other issues were identified e.g., outdated package inserts being used, labels having outdated excipients listed, etc.