Noise2Music -one of the applications of AI. At Tekedia AI in Business Masterclass, we educate on how AI is transforming markets and industries, with applications in many domains.  Learn more about our AI application cases here https://school.tekedia.com/course/aibusiness/

Tekedia Artificial Intelligence (AI) in Business Masterclass focuses on how AI (artificial intelligence) will redesign the world of business, and re-architect economies even as it transforms markets, communities, and organizations.  Participants will gain the knowledge capabilities, and confidence, required to support the integration of AI systems into their organizations, and advance their professional careers.

Coordinated by Tekedia Institute Lead Faculty, Prof Ndubuisi Ekekwe (doctoral degrees in electrical/computer engineering with specialization in robotics & neuromorphic engineering, and Banking & Finance), the multidisciplinary program runs for 8 weeks.

Noise2Music -one of the applications of AI. At Tekedia AI in Business Masterclass, we educate on how AI is transforming markets and industries, with applications in many domains. Learn more about our AI application cases here https://t.co/f9eR0TU6wi pic.twitter.com/KHkBNz0bB1

— Ndubuisi Ekekwe (@ndekekwe) September 17, 2023

All things are in constant flux. Embedded in the manifest disharmony is the beauty of harmony. This is a fact we rarely recall when we experience the sinusoidal nature of life. We may find ourselves walking through the vagaries of life with fragile mindsets, ill-prepared for the quotidian dialectics. Many people remain trapped for a long time as a result of this.

Usually when life happens, people generally have one or more things they are conditioned to do and which they believe enable them to cope. For example, some resort to taking alcohol or drugs, some inordinately quiz themselves or blame others for their lot. These invariably lead to a loss of self-esteem, hence, are not sustainable ways to address problems.

Across many world religions and philosophies, three things are often evident when the question of how man is able to overcome challenges and evolve in his environment arises. These include the soul (essence, substance, talent) of man, the power of believing and man’s capacity for thought or reason. The essence of these resources and how they could be put to use are discussed as follows:

Connecting and engaging your Soul

The soul is one of the greatest gifts of life we possess as living beings. Our soul represents the presence of universal intelligence in us. We cannot see it but we can connect with and feel it. However, one thing that we must learn is how we can make the best of this gift. The soul is our closest and most trusted ally. The soul is the light of man and connects man’s physical and spiritual existences.

Characteristic of the soul is the power of intuition which resolves questions that are mostly evasive to logic. The essence of the soul is to guide man and explain to him the many conundrums of life. Information flows from the spiritual or ethereal realm to the soul which passes and interprets it to man in the earthly symbols and language. Thus, when we are puzzled by life, our greatest defence is seeking solace from the soul.

There is no place as quitting and comforting as the human soul – Marcus Aurelius

How to connect with the soul? Iyanla Vanzant, a motivational writer, answered this in a somewhat idealistic and melancholic style. She thought invoking the soul should be done through a pool of emotion such as sequestering yourself, being far removed from the noises and distractions of the world, to cry over your affairs like an innocent infant would gear up its mother to come to its aid as a result of a threat it encountered in its environment. This according to Vanzant is not to hurt yourself but to jolt your soul from the ether to intervene in your worldly affair.

‘’Even there is a great cure in profound tears for it cleanses the body and clears up the head and the mind,’’ Iyanla Vanzant.

While the soul is a great resource with which to live our lives, it is perishable, hence must be constantly renewed. In order not to allow the soul to degrade, it is believed that one must avoid doing these five things:

1. Being constantly disgruntled at everything that fate has brought you with
2. Turning your back against other people or plotting to do them harm
3. Allowing oneself to be overwhelmed by pleasure, pain or the thought of other people’s
4. Thriving on falsehood and pretense
5. Doing things randomly and disconnected without purpose

Exercising the power of belief

Belief is an adaptive feature of man. Belief directs and emboldens our focus; it saves us from distractions and directs our attention to that which is believed in. Belief is not only therapeutic and psychologically relevant; it also brings about order in humanity as it helps us to quell the urge for immediate gratification which invariably spurs conflicts in society.

It is understandable that questions of belief and faith are often taken with a grain of salt in the realm of science which dwells mostly on reason and facts. However, it is ironical that most scientific breakthroughs have been possible due to the power of belief. Believing brings you inner peace. It will keep you going until you are out of the mazes and get to your destination.

Embracing the All in thought while you observe as things unfold

Everything in nature, from atoms to matter and to the heavenly bodies, like the sun, the moon, the stars and the galaxies exist mainly that we can live and reflect on them. And things must not be seen in isolation of the other related things and the general nature and the laws that bind them all. Observing nature this way will not only increase your capacity for thought but will also give you pleasure and a sense of beauty while you experience the interconnection of things.

You can observe the constantly flowing river and learn from it’s the greatness that is embedded in kindness and generosity. You can also observe the stars in the stark night.

‘’even nature’s inadvertence has its own charm, its own sensitivity – will find it all gives pleasure… dwell on the beauty of life. Watch the stars, and see yourself running with them,’’ Marcus Aurelius.

Resource:
Ismail A. Tiamiyu (2019). Ghaib: The Voyage of the Unseen. SAO Multiventures

The distribution of pharmaceutical products is an important component activity in the Supply chain and involves several players. It consists of procuring, holding, supplying, importing and exporting of pharmaceutical products.

Distribution activities are carried out by manufacturers, importers, wholesalers/distributors,retailers and other persons authorized to supply pharmaceutical products in the public and private sectors.

The Good Distribution Practice (GDP) guidelines forming the focus of this article are intended to help players in the supply chain of pharmaceutical products comply with NAFDAC Good Distribution Practice Regulations.

What are the objectives of the GDP guidelines?

-The GDP guidelines prescribe the minimumrequirements for good distribution of pharmaceutical products. 

– The GDP guidelines provides appropriate tools to assist all categories of distributors in conducting their activities in order to maintain the quality of pharmaceutical Products and prevent counterfeits from entering the legal supply chain.

-The guidelines are intended to help in minimizing the inherent risks in distribution such as mix-ups, adulteration, contamination, cross contamination and diversions.

What is the applicability scope of these guidelines?

-These guidelines apply to persons and entities involved in any aspect of the Distribution of pharmaceutical products from the manufacturing site to the point of sales or use. 

– The guidelines apply but are not limited to governments at all levels, non- governmental organizations, public and private health and storage facilities, manufacturers of finished pharmaceutical products, importers, exporters, wholesalers/distributors,suppliers, pharmacy retailers.

– Some sections of these guidelines also apply to other entities involved in the distribution of pharmaceutical products such as clearing and forwarding agents, freighters and transporters. 

– The guidelines also apply to distributors that are established or operating in Customs areas, such as free zones or free warehouses.

Which persons fall under the exemptions to the applicability scope of the guidelines?

-The guidelines do not apply to holders of Patent and Proprietary Medicine Vendors’ License (PPMVL) as the activities of this group are covered under Good Dispensing Practices.

-The document is to be used in conjunction with other existing relevant Pharmaceutical product statutes in the country. The good practices outlined Below are to be considered general guides, and they may be adapted to meet Individual needs as the distributor achieves compliance with regulatory Objectives.

What are the responsibilities assigned to relevant parties under the guidelines?

-All parties involved in the distribution of pharmaceutical products have a responsibility to ensure that the quality of pharmaceutical products and the integrity of the distribution chain are maintained throughout the distribution process from site of the manufacturer to the entity responsible for dispensing or providing the product to the patient.

-The principles of good distribution practice (GDP) are applicable both to pharmaceutical products moving forward in the distribution chain from the manufacturer to the entity responsible for dispensing or providing the product to the end user; and to products which are moving backwards in the chain such as it obtains in return and recall

-The principles of GDP are also applicable to donated pharmaceutical products.

-All distributors should apply due diligence with adherence to the principles of GDP, for example, in procedures relating to traceability and in recognition of security risks.

-All distributors should comply with the extant national legislations on pharmaceutical products.

-All distributors should be appropriately authorized and can be held accountable for all the activities that relate to the distribution of pharmaceutical products.

– Only entities which have marketing authorization for pharmaceutical products or their agents are entitled to import or export pharmaceutical products.

-Pharmaceutical products may be distributed within or to a country or territory if a marketing authorization or similar authorization has been granted, which allows the use of that pharmaceutical product in that country or territory.

-Holders of an authorization to distribute pharmaceutical products should obtain their supplies only from persons or entities which are in possession of the applicable authorization to sell or supply such products.

-Distributors or their agents should supply pharmaceutical products only to persons or entities which are themselves authorized to acquire such products either in terms of an authorization to act as a distributor or to sell or supply products directly to a patient .

What are some of the GDP principles highlighted in the guidelines?

-The correct distribution of pharmaceutical products relies upon people. For this reason, there must be sufficient number of competent personnel to carry out all tasks for which the distributor is responsible. Individual responsibilities should be clearly understood by employee and be recorded.

– There should be an adequate organizational structure defined with the aid of an organizational chart for each distributor. The responsibility, authority and interrelationships of all personnel should be clearly indicated.

– Duties and responsibilities should be clearly defined and understood by the individuals concerned and recorded as written job descriptions. The position of the superintendent pharmacist as required by law for the supervision of activities should be well defined. 

-At every level of the supply chain, employees should be fully informed and trained in their duties and responsibilities.

-A designated person should be appointed within the organization, who has defined authority and responsibility for ensuring that a quality management system is implemented and maintained.

-Managerial and technical personnel must have the authority and resources needed to carry out their duties and to set up and maintain a quality management system, as well as to identify and correct deviations from the established quality management system .

-The responsibilities placed on any one individual should not be so extensive as to present any risk to product quality.

-There should be arrangements in place to ensure that management and personnel are not subject to commercial, political, financial, and other pressures or conflict of interest that may have an adverse effect on the quality of service provided or on the integrity of pharmaceutical products.

-Safety procedures relating to all relevant aspects including the safety of personnel and property, environmental protection and product integrity should be in place.

What are the provisions of the guidelines regarding personnel?

-Key personnel involved in the distribution of pharmaceutical products should have the ability and experience appropriate to their responsibility for ensuring that pharmaceutical products are distributed properly.

– Personnel involved in the distribution of pharmaceutical products should wear garments suitable for the activities that they perform. 

– Personnel dealing with hazardous pharmaceutical products, including products containing materials that are highly active, toxic, and infectious or sensitizing, should be provided with Personal Protective Equipment (PPE) as necessary.

– Procedures and conditions of employment for employees, including contract and temporary staff, and other personnel having access to pharmaceutical products must be designed and administered to assist in minimizing the possibility of such products coming into the possession of unauthorized persons or entities.

– Codes of practice and punitive procedures should be in place to prevent and address situations where persons involved in the distribution of pharmaceutical products are suspected of, or found to be implicated in, any activities relating to the misappropriation, tampering, diversion or counterfeiting of any product.

– Appropriate procedures relating to personnel hygiene, relevant to the activities being carried out, should be established and observed. Such procedures should cover health, hygiene and clothing.

Who exactly is a “Responsible person” under the guidelines?

– All distributors under the guidelines must designate a person as a responsible person who is the superintendent pharmacist. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.

– The responsible person should fulfill their responsibilities personally and should be continuously contactable. 

– The responsible person may delegate duties but not responsibilities.

– The written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. The distributor should give the responsible person the defined authority, resources and responsibility needed to fulfill their duties.

-The responsible person should carry out their duties in such a way as to ensure that the distributor can demonstrate GDP compliance and that obligations to the public are met. 

-The responsibilities of the responsible person include:

a.Ensuring that a quality management system is implemented and maintained;

b.Focusing on the management of authorized activities, the accuracy and quality of records;

c.Ensuring that initial and continuous training programmes are implemented and maintained;

d.Coordinating and promptly performing any recall operations for pharmaceutical products;

e.Ensuring that relevant customer complaints are dealt with effectively;

f.Ensuring that suppliers and customers in the distribution chain are approved;

g.Approving any subcontracted activities which may impact on GDP;

h.Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;

i.Keeping appropriate records of any delegated duties;

j.Deciding on the final disposition of returned, rejected, recalled or falsified products; k.Approving any returns to saleable/useable stock;

l.Ensuring that any additional regulatory requirements imposed on certain products are adhered to.

What are the provisions of the guidelines on training?

– All personnel involved in distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks. Training should be based on written standard operating procedures (SOPs).

-Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. The responsible person should also maintain their competence in GDP through regular training.

– In addition, training should include aspects of product security, as well as aspects of product identification, the detection of counterfeits and the avoidance of counterfeits entering the supply chain.

-Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), as well as time and temperature-sensitive products.

– A record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.