Regulatory Affairs as a Business Partner

Today's urban society is inclined to buy practical, ready-to-cook food and ready to eat. Ready of cook means thatit takes less time to prepare food. One form of food that is ready to cook is a nugget. Fish nuggets are very easy to processand the raw material of tuna is easily obtained in Lere urban village. aims to empower communities around the campuswith a commercial business orientation and accelerated the development, coaching, creati on of network marketing results,continuously. Using Community Education methods with Participatory Rural Appraisal (PRA/ RRA), training methods,demonstration experiments, and coaching and evaluation of small business partner groups. The demonstrationdemonstration demonstration demplot was conducted with the introduction of technology covering fish nugget processingtechnology. The result of this training activity is the Improvement of ability in running the partner business through thetraining activity that is held. Increasing the capability and income of community partners activities with the existence offish processing technology into nugget is one of food diversification and food preservation

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Transforming HR to a Strategic Business Partner: Meaning, Required Competencies; Mindset; Challenges and Prospects.

SSRN Electronic Journal ◽

10.2139/ssrn.2691299 ◽

2015 ◽

Author(s):

Samuel Dare Ajayi

Keyword(s):

Business Partner

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Applied Drug Research, Clinical Trials and Regulatory Affairs

10.2174/adctra-26673371-188227 ◽

2020 ◽

Keyword(s):

Clinical Trials ◽

Drug Research ◽

Regulatory Affairs

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Differences between the European Union and United States of America in Drug Regulatory Affairs Affect Global Patient Safety Standards and Public Health Awareness: The Case of Deferasirox and Other Iron Chelating Drugs

Medicines ◽

10.3390/medicines8070036 ◽

2021 ◽

Vol 8 (7) ◽

pp. 36

Author(s):

George J. Kontoghiorghes

Keyword(s):

Patient Safety ◽

Generic Drugs ◽

Benefit Assessment ◽

Regulatory Control ◽

Pharmaceutical Companies ◽

The European Union ◽

Regulatory Policies ◽

Regulatory Affairs ◽

Risk Benefit Assessment ◽

The Eu

Regulatory policies on drugs have a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, leading sometimes to irregularities and illegal activities. Misinformation on the orphan drug deferasirox has reached the stage of criminal investigations and fines exceeding USD 100 million. Additional lawsuits of USD 3.5 billion for damages and civil fines were also filed by the FBI of the USA involving deferasirox and mycophenolic acid, which were later settled with an additional fine of USD 390 million. Furthermore, a USD 345 million fine was also settled for bribes and other illegal overseas operations including an EU country. However, no similar fines for illegal practises or regulatory control violations have been issued in the EU. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison to deferiprone and deferoxamine appear to reduce the effective treatment prospects and to increase the toxicity risks for thalassaemia and other iron loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patented versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly market driven with no clear safeguards or guidelines for risk/benefit assessment indications or for individualised effective and safe optimum therapies. There is a need for the establishment of an international organisation, which can monitor and assess the risk/benefit assessment and marketing of drugs in the EU and globally for the benefit of patients. The pivotal role of the regulatory drug authorities and the prescribing physicians for identifying individualised optimum therapies is essential for improving the survival and safety of millions of patients worldwide.

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