12^th International Conference and Exhibition on Pharmacovigilance & Drug Safety June 21-22, 2018 Rome, Italy

Aaron Damien Barzey was the Global Labelling lead for the orphan drug ‘ofatumumab’. He was responsible for the company core datasheets, labelling strategy, EU labelling negations and oversaw the product launch in emerging markets. The major accomplishment was leading the launch of Arzerra for the treatment of chronic lymphatic leukaemia across the EU, Australia and other countries. In 2015 Aaron started his own regulatory consultancy, ADB Medical, providing ad-hoc support or project specific guidance to various companies. In 2016 Aaron was chosen as the pharmaceutical industry SME to discuss the possible impact of Brexit on the pharmaceutical industry, which included debating with Nigel Farage live on national television and to discuss further on live on UK TV with Piers Morgan and Susanna Reid.

The European Union (EU) has led the way in pharmacovigilance legislation, processes and understanding for many year and are the global leader in the review and approval of Biosimilars medicines, orphan drugs and paediatric medicines via the London based European Medicines Agency (EMA). Other countries, such as Australia, work side by side with the regulations and guidance produced from the EMA, and institutions, such as the World Health Organisation, have periodic meetings in London to discuss medicines. The United Kingdom is due to leave the EU on 29th March 2019 and the EMA and all its staff will have to relocate to remain in the EU as a result. All centralised registered products will need to be re-registered to one of the remaining 27 countries and there is the very real risk that this relocation will see losses in talented staff as well as hinder the approval and maintenance of innovative medicines and the maintenance of the current pharmacovigilance reporting mechanisms.

Sanjeev Miglani is an MD in internal medicine and has over 18 years of experience in the field of medicine, Pharmacovigilance and clinical research. He is the Vice President of Safety and Medical Affairs at APCER. Just before joining APCER, Sanjeev was the vice president for Pharmacovigilance and medical writing at Accenture. before joining Accenture, Sanjeev was the COO Officer and Scientific Director of CIDP Biotech. Prior to CIDP, Sanjeev was the Director of Medical Affairs at CliniRx. Before CliniRx, He has worked with Ranbaxy as a senior manager in the department of medical affairs and pharmacovigilance. He has also worked as a senior resident in cardiology and medicine department in some of the prestigious hospitals of New Delhi. He is a life time member of API and a fellow of Indian Association of Clinical medicine. He has numerous publications in medical journals and books to his credit.

The aim of this study was to assess levels of depressive symptoms present in patients with diabetic foot. A convenience sampling method was used to recruit 108 patients with diabetic foot. After having completed the Center for Epidemiologic Studies Depression Scale (CES-D), patients' demographic data and medical history were collected using pre-structured forms. Of the entire sample, 38.9% have CES-D score ≥27 which indicates risk for major depression. Logistic regression analysis showed that retinopathy was significantly associated with increased depressive symptoms among diabetic foot patients (odds ratio 3.41 (p=0.017)). Being on a combination of oral hypoglycemic agents and insulin treatment was significantly associated with lower depressive symptoms (odds ratio 3.38 (p=0.022)). Patients with primary education level have the highest odds ratio among all factors associated with risk for major depression (OR, 4.07; p=0.003). The risk for major depression among patients with diabetic foot in Jordan is high compared to general diabetic population. This was associated with low educational level, retinopathy and not taking combination of oral hypoglycaemic agents and insulin. There is a need for routine screening for depression in patients with diabetic foot to help in the prevention, early detection of depression and even referral to a psychiatrist.

Jyoti B Sharma has completed her Master’s degree in pharmacology and working as research associate in the Department of Clinical Pharmacology, Tata Memorial Centre, Mumbai, India. She is involved in early phase clinical trials (phase 1) as a young researcher and also a co-investigator and presently coordinating the biosimilar trial. She is also involved in the clinical studies like bioequivalence, therapeutic drug monitoring and collecting the adverse drug reaction data in oncology in renal cancer, hepatocellular cancer, lung and prostate cancer. She has one patent in process and two publications.

Cristina Scavone is a pharmacist attending the last year of PhD in translational medicine. She plays her scientific research as a PhD student at the Department of Experimental Medicine of University of Campania “Luigi Vanvitelli” and at the Pharmacovigilance and Pharmacoepidemiology Center. Her research activities are directed to the topic of pharmacovigilance and pharmaco epidemiology. Since 2014, she is a member of the Italian Society of Pharmacology.

Kety Mirkovic Kos is a passionate multilingual pharmacovigilance and regulatory expert with comprehensive domestic and international work experience and 60+ completed courses and trainings in the fields of  pharmacovigilance, regulatory affairs management, consultancy and quality assurance.

Additional risk minimisation measures pose a challenge to both industry and the regulators. Applicants are obliged to actively monitor safety profile of their medicinal product and to anticipate its important safety risks, based on their own experience or information already available for originator products licensed in the EU. Croatian legislation on pharmacovigilance was last updated around the time of accession to the EU. Any further update is presented through the publicly available news section on HALMED website. Especially news concerning nationally licensed medicinal product are obliging for MAHs for Croatia. Important safety information is usually first communicated to the HCPs via DHCPs and later on in aRMM, following particular country-specific protocols. Request for common aRMM assessments is strongly supported by HALMED, with educational materials on generic name, version and HALMED approval date inserted. Approval costs for the initial aRMM materials and their update is the same, with approval timelines from 6 months to 1.5 years with tendency to decrease. Preparation of common PASS/PAESS studies may be requested by the NCA, irrespective if the licensed medicinal product is marketed in Croatia. What can the industry do to decrease costs and enhance product safety?

Mugdha Chopra is a dentist by qualification and has over 14 years of experience in the field of dentistry, and pharmacovigilance. She is associate vice president for US PV and clinical safety at APCER and oversees the delivery and operations from India which includes but not limited to case processing aggregate reporting, literature Monitoring and signal detection. Before joining APCER, she was with Ranbaxy as a manager in the Department of Medical Affairs and pharmacovigilance. She comes with an extensive experience in various safety databases like Argus Safety and ARISg for case processing, reporting, and product/license management and has also met the challenges of business continuity planning and data restoration.

Oncology studies are required to be very intensively monitored than studies from many of the other therapeutic areas, because of the nature and severity of the disease and the complexity and potential toxicity of the treatment or the use of newer approaches such as biologics and personalized medicine. In oncology trials unlike the clinical trials in many of the other therapeutic areas, a higher number of subjects are likely to develop serious adverse events and these cases are often complex. The evaluation of drug event relationship and distinguishing from underlying disease and concomitant therapies can be very challenging. Many oncology trials are conducted in high mortality diseases and at times have efficacy endpoints that could also be reportable adverse reactions. The breaking of the blind for such cases as required for expedited reporting to regulatory authorities could compromise the integrity of the clinical trial. In such scenarios, it is advisable to reach agreement with regulatory authorities in advance concerning serious adverse events (SAEs) that would be considered disease related and not subject to systematic unbinding and expedited reporting. Making sure patient compliance with the necessities of a clinical study is quintessential to the success of a study meeting its intended objectives. Therefore, it is imperative to have experienced medical oversight throughout the design, implementation and reporting throughout all phases of a clinical development program. Safety monitors provide tactical drug development guidance as well as review key study documents and safety information and act as the prime medical resource to support the investigators and sites involved in the clinical trials. This session will describe the importance of safety in oncology trials, and how a rigorous and thorough monitoring can lead to the smooth conduct of oncology clinical trials.