Summary of Rol del Químico Farmacéutico en el Área de Asuntos Regulatorios en el Sector Público

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00:00:00 - 01:00:00

The role of the pharmacist in regulatory affairs in the public sector is crucial for ensuring the safety and efficacy of pharmaceutical products. This video covers various aspects of the role, including language proficiency, scientific knowledge, communication skills, and the importance of regulations and regulatory frameworks. The video emphasizes the need for continuing professional development and adapting to changes in the industry to stay competent in the field. The video also discusses the testing process for drugs and the Químico Farmacéutico's role in evaluating and monitoring the quality, safety, and efficacy of pharmaceutical products.

00:00:00 In this section, the speaker introduces the guest speaker, Dr. Mirta Herrera Rivas, who has 21 years of experience in the area of regulatory affairs for pharmaceutical products. She has received extensive training in product evaluation, equivalent studies, and techniques for analytical medication validation. Dr. Herrera Rivas is currently working as a specialist in regulatory affairs for the National Authority of Pharmaceutical Products, Medical Devices, and Sanitary Products. She is deemed an excellent example for pharmacy and biochemistry students to follow.
00:05:00 In this section, the speaker discusses the role of the pharmacist in regulatory affairs in the public sector, emphasizing the importance of human resources for ensuring the safety and efficacy of medicines. The presentation touches on the regulatory process, the functions of regulatory authorities, and the legal requirements for authorizing a medicine. The speaker stresses the need for pharmacists working in regulatory affairs to have a diverse skill set that includes both personal qualities and specific abilities. Overall, the speaker highlights the vital role that pharmacists play in ensuring the safety and efficacy of medicines for the public.
00:10:00 In this section, the role of the pharmacist in regulatory affairs in the public sector is discussed. One important aspect is language proficiency, particularly in English since most product dossiers submitted to regulatory authorities are from foreign countries. The pharmacist must be able to understand and apply international regulations and guidelines properly. Another aspect is the development of a strong scientific knowledge base that is both extensive and methodical. The pharmacist must also possess good communication skills, as they will be handling and transmitting important information that must be understood by others. Effective communication can generate positivity within interpersonal relationships and improve overall workplace morale.
00:15:00 In this section, the speaker discusses the importance of developing skills and competencies for pharmaceutical regulatory affairs professionals in the public sector. The complexity of the regulatory authority's functions will determine the number of pharmacists needed, which can range from 300 to even 1,000 internationally. Effective communication and leadership skills are necessary to maintain a good relationship with colleagues and administrative staff to carry out the regulatory authority's functions correctly. The knowledge and skills acquired in undergraduate studies, such as organic chemistry and physiology, are not enough, and professionals must continually update their skills and stay competent to take on more specialized roles in the organization.
00:20:00 In this section, the video discusses how the role of regulatory affairs in the pharmaceutical industry has changed in recent years in Peru. Prior to 2019, the registration process for pharmaceutical products was automatic with minimal requirements. However, changes in regulations due to free trade agreements have opened up opportunities for pharmacists to become more involved in regulatory affairs. The video emphasizes the importance of pharmacists acquiring the necessary competencies and skills to navigate these changes and effectively communicate in a team-oriented and assertive manner. Additionally, access to scientific knowledge and guidelines is now readily available through the internet and social media, allowing pharmacists to continue to develop their expertise in this area.
00:25:00 In this section, the importance of regulation in the pharmaceutical sector is discussed. Medications are not just commodities, they hold a high social value and it's important to ensure that they are safe, effective, and of high quality for consumers. A regulatory system is necessary to guarantee this, and it involves components such as manufacturers complying with high standards for production, regulatory authorities evaluating the safety and efficacy of products, and responsible parties ensuring quality control. All of these elements are critical for a successful regulatory system in the pharmaceutical industry.
00:30:00 In this section, the importance of regulatory frameworks for ensuring the safety, quality, and efficacy of pharmaceutical products is emphasized. National and international regulations must be followed, and institutions and professionals that do not comply must face sanctions. Regulatory authorities play a crucial role in ensuring that products meet acceptable standards of quality, efficacy, and safety. They must ensure that both the product and the facilities that produce it meet good manufacturing, storage, and distribution practices. To perform all of these functions, regulatory authorities require a well-trained and knowledgeable workforce. The regulatory process requires that establishments be authorized before being allowed to produce or market products, and inspectors must certify that establishments meet certain requirements. Finally, a dossier must be submitted for a product before it can be marketed, and the regulatory authority must evaluate it to ensure that it meets all necessary requirements.
00:35:00 In this section, the speaker explains the role of the pharmacist in regulatory affairs in the public sector. The pharmacist ensures that the products used are safe, effective, and of quality by granting the products a health registration. The pharmacist also monitors the quality of the products and controls their promotion and advertising to prevent self-medication. The pharmaceutical authority must fulfill certain requirements, such as having competent human resources, regulatory guidelines, financing, and infrastructure, to carry out their basic functions effectively. In Peru, the responsibility for regulating these functions falls under the direction of the General Directorate of Medicines, Medical Devices, and Drugs.
00:40:00 En this section, the role of the pharmacist in regulatory affairs in the public sector is discussed. The pharmacist is responsible for ensuring the safety and efficacy of pharmaceuticals, biologics, medical devices, and sanitary products through the authorization process. The pharmacist is also responsible for the inspection of products and establishments, as well as overseeing control, surveillance, and vigilance to combat illegal commerce. To assume these demanding roles, pharmacists must continually update their skills in management, leadership, and administration. The challenge lies in consolidating our expertise to bolster competency and justify a rightful place in the ever-evolving field of regulatory affairs.
00:45:00 In this section, the role of the chemical pharmacist in regulatory affairs is discussed, specifically in terms of determining the safety and efficacy of drugs. The testing process involves preclinical studies in animals to determine the minimum lethal dose and potential toxicity, followed by clinical studies in healthy individuals and eventually in patients with the disease being targeted. The studies involve evaluating the pharmacokinetics, pharmacodynamics, and quality of the drug, as well as obtaining approval from regulatory authorities before the drug can be released to the public.
00:50:00 In this section, the role of the Químico Farmacéutico (pharmaceutical chemist) in the Área de Asuntos Regulatorios (regulatory affairs) in the public sector is discussed. The Químico Farmacéutico's role in regulatory affairs includes evaluating and approving the dossier presented for a product's registration with the regulatory authority. After approval, the Químico Farmacéutico's responsibilities include post-commercialization monitoring, including regular product quality inspections, and farmacovigilancia to ensure that the benefits of the product outweigh the risks in the market. Additionally, compliance with good laboratory practices, manufacturing, and quality control is monitored. Overall, the Químico Farmacéutico in regulatory affairs plays a critical role in ensuring the quality, safety, and efficacy of pharmaceutical products in the market.
00:55:00 In this section, the speaker discusses the role of the pharmacist in regulatory affairs in the public sector. They mention the importance of technical specifications, analytical techniques, stability, and quality control of the active pharmaceutical ingredient. Additionally, they explain that after an innovative product has undergone extensive research and development, it is given a patent for 20 years. Once the patent expires, other companies can produce copies of the product, called multifuentes. Multifuentes must meet the same quality standards as the innovative product, but only need to present studies on therapeutic equivalence to prove the product works in the same way. The speaker also mentions the importance of following good manufacturing practices and pharmacovigilance, and how a technical document is common to many countries to help harmonize the approval process.

01:00:00 - 01:15:00

The video focuses on the importance of pharmacist's role in regulatory affairs in the public sector, emphasizing the guidelines provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the need for professionals to be familiar with them. It also mentions the importance of understanding pharmacopeias, investigating countries with high drug safety standards, and the legal framework for authorizing drugs. The speaker highlights the necessity for training in this field and the need for developing competencies and integrity among pharmaceutical chemists while encouraging aspiring pharmaceutical chemists to consider a career in this field. Finally, the speaker emphasizes the need for continuous learning and development throughout their professional career.

01:00:00 In this section, the speaker discusses the importance of a pharmacist's role in regulatory affairs in the public sector. They mention the guidelines provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the need for professionals to be familiar with them. Additionally, they highlight the importance of understanding pharmacopeias as a way of ensuring product quality, as well as the need to investigate countries with high drug safety standards. The speaker emphasizes that a lack of regulatory capability can lead to irrational drug consumption and lower quality products, which can have negative consequences for public health. Lastly, they mention the legal framework for authorizing drugs and the importance of keeping up with updates and changes to ensure compliance.
01:05:00 In this section, the speaker discusses the various components of a regulatory dossier in the pharmaceutical sector, including validation of analytical methods, process variation, stability studies, technical specifications, labeling, and certificate of compliance. They also touch upon the importance of a risk management plan and the process for presenting preclinical and clinical studies to substantiate the safety and efficacy of a product. The speaker emphasizes the necessity for training in this field to perform these regulatory duties effectively. Additionally, they respond to questions from the audience regarding laboratory regulations, clinical trials, and entering the regulatory field.
01:10:00 In this section, the speaker emphasizes the importance of developing competencies and integrity among pharmaceutical chemists who wish to work in areas of regulatory affairs, particularly in authorizing products that will be used by the public. The speaker highlights the need for standardizing the curriculum of universities to include more information and training in regulatory affairs, and for offering internships at regulatory authorities to provide real-world experience. Additionally, the speaker suggests the importance of developing soft skills and management skills, as the field of regulatory affairs has expanded beyond just authorizing establishments and into various areas such as post-market surveillance, good manufacturing practices, and pharmacovigilance. Overall, the speaker expresses their passion for the regulatory field and encourages aspiring pharmaceutical chemists to consider a career in this field.
01:15:00 In this section, the speaker emphasizes the importance of the role of a pharmaceutical chemist in regulatory affairs in the public sector. He believes that to assume the challenge, one must have relevant skills and abilities to lead a team of chemists. He urges them to unite and put their differences aside to achieve common goals, just like doctors do when there is a problem. He also stresses the significance of continuous learning and development throughout their professional career. Finally, he expresses his gratitude to the presenter and calls for more spaces like this to share knowledge and experiences.