VENUE FOR GMP-FMT-VIS ON 15 OCTOBER 2019 AND QCFRR-VIS ON 16-17 OCTOBER 2019. For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. You will never know what exactly you are getting. Bogotá, Colombia. Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in NORTHVIEW HOTEL, BRGY. It is alarming that they also offer services such as intravenous drip or infusion using skin lightening agents including reduced glutathione, vitamin C and other injections. © Copyright 2002-2020 - International Society of Pharmacovigilance I Site designed and developed by REASON, International Society of Pharmacovigilance. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. Formulário Farmacêutico Magistral. For more information and inquiries, please e-mail us at [email protected]. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. This section contains an overview of products and measures to ensure the safe use of medicines. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). Please be informed that the venue of the GMP-FMT for Visayas Stakeholders, Course Code: GMP-FMT-Vis on 15 October 2019 and Center for Food Regulation and Research QPIRA Seminar on 16-17 October 2019 will be in THE MANSION ILOILO, 101 GENERAL LUNA STREET, ILOILO CITY.. All registrants who received … Autor de livros na área farmacêutica, médica e hospitalar: Medicamentos Injetáveis em Terapia Intensiva Pediátrica. Farmaco Vigilancia El Salvador. Blindness can also happen in severe cases. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility. In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. Thus it is exciting to have an ISoP Annual Meeting for the third time in two decades in the region. Laboratory testing of the product is also being undertaken to check if the methanol content is compliant. This is in light of recent reports that alcopops, sweet and often fruit-flavored or fizzy alcoholic beverages, are being sold by retailers, such as supermarkets, groceries and convenience stores to minors, alongside with juice drinks and other non-alcoholic beverages. This is in consideration to the reinstatement of the HUHS licensing and notification requirements. Dissemination of the information to all concerned is requested. The FDA recommends purchase of medicines from licensed pharmacies near you and seek advice from your community pharmacist on the proper and safe use of medicines. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. Attachment-> : RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR. Attachment:-> VENUE FOR UNIFIED LICENSING SEMINAR (ULS-RVII) ON 17 OCTOBER 2019. Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. Grupo Destinos Gilberto Barcelos Souza. What is ISoP? To assure that your skin conditions are treated, consult only a board-certified dermatologist. Further, the FDA has requested the assistance of the Epidemiology Bureau of the Department of Health to ensure that proper information from the patients relative to this incident is collected and verified. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected] (for ENDS/ENNDS-related concerns) or [email protected] (for HUHS, HUP, PCO and Toy-related concerns). El Centro Nacional de Farmacovigilancia y Tecnovigilancia (CENAFyT) les presenta en este primer boletín del 2019, el cual contiene artículos de actualidad y de interés profesional. Attachment->:ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC). All Local Government Units and Law Enforcement Agencies are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction. We hope that you will find the meeting and your stay in Bogota both energizing and enjoyable, and we look forward to welcoming you next October! This is also a product of natural fermentation and is found in both alcoholic and non-alcoholic fermented beverages. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. Trabalha na Farmácia do HUAP. To date there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. Attachment-> : VENUE FOR QCCRR-MIN ON 29-30 AUGUST 2019 AND ULS-RX ON 30 AUGUST 2019. Please be informed that the conduct of ULS-RII in Isabela (Course Code:ULS-RII) scheduled on 18 July 2019 shall be postponed due to Typhoon Falcon that is expected to land in Northern Luzon this week. ChinaPharmacovigilance systems in China: Moving to the next step. All concerned regulated establishments are reminded to follow and strictly comply with the FDA’s existing rules and regulations to ensure that only safe and quality products shall be made available to the public. Attachment-> : VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019. Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on 17-18 July 2019 within Davao City shall be rescheduled to 3-4 December 2019 and GMP-FMT Seminar (Course Code: GMP-FMT-MEC) on 19 July 2019 shall be rescheduled to 5 December 2019. Currently, this product is not registered with the FDA. Attachment-> : Press Release 22 August 2019. Attachment-> : ULS DAVAO VENUE on 22 August 2019. Course Assessment Slip of Pharmacovigilance, Risk Minimisation Methods for Asian countries Group, PV Professional Qualification Framework Group, ISoP General Assembly 14/10/20, 18.00 UTC (by video-conference), Article published by NZ Pharmacy Today magazine about World Pharmacist Day and the ISoP statement in support of pharmacists worldwide, ISoP statement in support of World Pharmacist Day, 25 September 2020, New ISoP infographic ‘Using Medicines Safely during the COVID-19 pandemic’. The International Society of Pharmacovigilance (ISoP) is an international non-profit scientific organisation, which aims to foster Pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries. Please be informed that the venue of the Unified Licensing Seminar (ULS – RVII) on 17 October 2019 will be in KEW HOTEL, J.A CLARIN STREET, TAGBILARAN CITY, BOHOL. 02 Guía de Farmacovigilancia para la elaboración del Reporte Periódico de Seguridad: 20-feb-2020: 03 Guía de Farmacovigilancia para la notificación de EA, SRAM, RAM, ESAVI o cualquier problema de seguridad relacionado con el uso de medicamentos y vacunas: 12-mar-2020: 04 Guía de Farmacovigilancia en Investigación Clínica: 17-jun-2020 Seek medical attention immediately if you experience any side effects and report it to FDA at [email protected] or via online reporting through our website: www.fda.gov.ph. Committed to safer use of medicines worldwide, 10-11 December 2020Intelligent Automation in Pharmacovigilance.READ MORE. The public is warned to exercise extreme caution in purchasing or consuming alcoholic beverages and advised to purchase and consume only those which are registered with the FDA. Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 29 August 2019 will be in PLAZA ALEMANIA, CORNER B. S. ONG STREET & GREGORIO T. LLUCH AVE. PALA-O, ILIGAN CITY. Further, retailers are reminded to include appropriate prominent signage for liquors/alcoholic drinks in their respective stores and ensure the conduct of appropriate verification of age of customers. Brian Edwards, Chair Scientific Committee Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in LA VENEZIA HOTEL & SPA, INC., RENAISSANCE GARDENS, WASHINGTON DRIVE, LEGAZPI CITY, ALBAY. The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation. VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RV) ON 19-20 JUNE 2019, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019, Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in, We advise our clients to kindly send all queries and concerns via, For more information and inquiries, please e-mail us at, Seek medical attention immediately if you experience any side effects and report it to FDA at, Center for Cosmetics Regulation and Research QPIRA Seminar for Mindanao (Cagayan de Oro), Unified Licensing Seminar for Region X (Iligan City), Unified Licensing Seminar for Region X (Cagayan de Oro City), For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at, Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on, Please be informed that the conduct of Center for Cosmetics Regulation and Research (CCRR) QPIRA Seminar for Household and Urban Hazardous Substance (Course Code: QCCRR-HUHS) on 16-17 July 2019 within Muntinlupa City, Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in, Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in, VENUE FOR UNIFIED LICENSING SEMINAR (ULS-RVII) ON 17 OCTOBER 2019, VENUE FOR QCCRR-MIN ON 29-30 AUGUST 2019 AND ULS-RX ON 30 AUGUST 2019, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RX) ON 29 AUGUST 2019, ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC), RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019, CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019, Presentation of IRR of RA10620: Toy and Game Safety Labeling Act of 2013. All confirmed participants of this seminar shall be automatically moved to the rescheduled date. Buying medicines over the internet can pose serious health risk. We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. I am honoured and delighted to have been elected as President of ISoP – as announced on 28th October 2019 at our Annual General Meeting in Bogota – and am especially proud to be the first woman to ever hold this role in our professional society. By virtue of FDA Personnel Order No. On 30 June 2019, the Food and Drug Administration (FDA) received a report on an incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’ and exhibited signs and symptoms related to methanol intoxication which include headache, vomiting, abdominal pain, and affected vision. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. Please be informed that the venue of the GMP-FMT for Visayas Stakeholders, Course Code: GMP-FMT-Vis on 15 October 2019 and Center for Food Regulation and Research QPIRA Seminar on 16-17 October 2019 will be in THE MANSION ILOILO, 101 GENERAL LUNA STREET, ILOILO CITY. Annual Meeting, We use cookies to improve user experience. Please be informed of the following changes of the FDA Academy QPIRA Seminar for Center for Cosmetics Regulation and Research for Mindanao Stakeholders (QCCRR-MIN) and Unified Licensing Seminar for Region X (ULS-RX) in observance of the local holiday in Cagayan de Oro City on 28 August 2019: Our sincere apologies for any inconvenience this change in seminar schedule have cause. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. Unlike other consumer products purchased over the internet, medicines have the potential to cause serious side effects and health problems if not used and stored properly. Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions. Drug Safety is the premier international journal covering the disciplines of pharmacovigilance, pharmacoepidemiology, benefit-risk assessment and risk management. It is important to seek medical advice from doctor or pharmacist before taking medicines. Members / Join / Access Drug Safety Journal, International Society “Ayúdanos a mejorar la salud, Si usted es profesional del área de la salud o un ciudadano comprometido con la salud y tiene una Notificación de Reacciones Adversas, de algún medicamento que usted consume o alguna persona que usted conozca, por favor háganos saber que problemas se presentaron en los siguientes formularios.” Cruz, Manila. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected]. Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in HOTEL GUILLERMO, RIZAL AVENUE, PAGADIAN CITY. Large doses of Vitamin C have resulted in hemodialysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. For inquiries and other concerns, you may reach the FDA Academy thru: Attachment-> : ULS-RII POSTPONEMENT ON JULY 18 2019. Farmacêutico. Manual de Drogas Injetáveis. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. Even if the medicines bought online looks the same; there is no guarantee that it is genuine. The confirmed participant of this seminar will be transferred to the next available seminar schedule. This is due to very low number of course participants that registered in the course. The FDA has not approved any injectable products for skin lightening. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. 2019-0523, please be advised that the Center for Cosmetics Regulation and Research (CCRR) will conduct a Cascading-Workshop on the new Administrative Orders on the Regulation of Electronic Nicotine Delivery Systems (END/ENDDS), Household Pesticide and Their Active Ingredients, Operators of Pest Control, Certification of Pesticide Handlers and Accreditation of Their Training Providers, Reinstatement of Licensing and Registration and or Notification of Household Urban Substances and Implementing Rules and Regulations of RA10620 on 15 to 16 of August 2019.On such dates, CCRR will not be able to entertain clients. Finally, an exciting and memorable social programme will be arranged including a complimentary conference dinner in the Colombian tradition of hospitality. To report continuous sale or distribution of the above unregistered food product, e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105. Upon receipt of DRF, the Releasing Officer checks on the files for release. isop2019bogota@grupodestinos.com.mx, ISoP 2019 Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 22 August 2019 will be in GRAND REGAL HOTEL DAVAO, KM. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. Anticorpos Monoclonais na Prática Clínica. The Department of Health – Food and Drug Administration released recently an advisory warning retailers on promoting and selling of alcoholic beverages to minors (below 18 years old). Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 14 August 2019 will be in CORNER ONE EVENTS HUB, CORNER MABINI SUPERHIGHWAY, APLAYA, DIGOS CITY, DAVAO DEL SUR. A Document Request Form (DRF) must be accomplished by the Client (Owner/President/Manager/Head of the company or the Authorized Representative) and submit to the Releasing Officer together with the required document/s mentioned above. The general public is enjoined to be vigilant from food retailers who continuously sell alcoholic beverages to minors. This is to inform all concerned stakeholders that the Cascading activities shall push through on 7 & 9 August 2019 at the DOH Convention Hall, DOH, Sta. The ISoP 2019 meeting itself will be a venue for the convergence of ideas, topics, experiences and approaches between speakers, special interest groups and participants of the various areas of expertise. Please be informed that the venue of the Center for Cosmetics Regulation and Research (QCCRR-Min) on 29-30 August 2019 and Unified Licensing Seminar (ULS – RX) on 30 August 2019 will be in APPLE TREE RESORT AND HOTEL, ZONE-2 TABOC, OPOL, MISAMIS ORIENTAL. Israel Chapter Webinar series2 September 2020READ MORE, Western Pacific Chapter meeting7 September 2020READ MORE, Moscow, Russia, Spring 2021Please note important informationMoving Pharmacovigilance Forward in the Eurasian Economic Union (EAEU)REGISTER NOW, Muscat, Oman, 11-14 October 2021Please note important informationIntegrated Pharmacovigilance for Safer PatientsREAD MORE, In line with the General Data Protection Regulation (GDPR). AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS: 2. In the Philippines, several health and beauty salons, wellness spa and beauty clinics are offering all kinds of beauty enhancements, services and skin treatments. There are also no published guidelines for appropriate dosing regimens and duration of treatment. Please be informed that the venue of the Unified Licensing Seminar (ULS – RXII) on 3 & 4 July 2019 will be in GREENLEAF HOTEL, SAN MIGUEL STREET CORNER J. CATOLICO AVENUE, LAGAO, GENERAL SANTOS CITY. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR. Authorization letter in company letterhead; Photocopy of valid ID of the Company’s Owner/President/Manager/Head; and. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE. To ensure health and welfare of minors and to remind retailers on the ethical sale of alcoholic beverages, the DOH-FDA is sternly reminding all retailers to refrain from the promotion and selling of all alcoholic beverages, especially alcopops, to minors. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations. Pharmacovigilance is a fast-growing science of global interest undergoing rapid development in regions such as Latin America over the last few decades. All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents: For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). The FDA hereby warns the public on the consumption of the implicated product as this is currently unregistered and has been confirmed to contain a high level of methanol. By continuing to use this website you are giving consent for us to set cookies. Releasing Officer releases the Authorization/s to Client. Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals. Please be informed that the conduct of ULS-ARMM in Cotabato City (Course Code:ULS-ARMM) scheduled on 2 July 2019 is cancelled due to very low number of course participants that registered in the seminar. Attachment-> : CDRR MEMORANDUM NO.2019-07. Rest assured that all changes and concerns of the registered participants of this seminar shall be attended to by the FDA Academy. Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX. Regular transactions will resume on Monday, 19 August 2019. A medicine bought online may contain no active ingredient; too much or too little of active ingredients which may result to your condition not being treated correctly. The ISoP 2019 meeting itself will be a venue for the convergence of ideas, topics, experiences and approaches between speakers, special interest groups and participants of the various areas of expertise. Attachment-> : VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RX) ON 29 AUGUST 2019. Attachment:->VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019. We are particularly happy to be present in this unique event and proud to have the opportunity to chair, share and exchange views, expectations and solutions with other high-level professionals, professors, colleagues and friends, representatives of well-recognized universities, institutes and organizations. Please be informed that the conduct of Center for Cosmetics Regulation and Research (CCRR) QPIRA Seminar for Household and Urban Hazardous Substance (Course Code: QCCRR-HUHS) on 16-17 July 2019 within Muntinlupa City shall be rescheduled to 3-4 October 2019. In light of the developments on the investigation of the Food and Drug Administration (FDA) with regards to the incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’, this Office shall order the seizure and/or confiscation of the product as the samples collected and subjected to FDA analysis were found positive for methanol. Upon validation, Releasing Officer hands-over to Client the second copy as FDA’s receiving copy indicating the printed name, signature, date and time of receipt. In the interest of public protection, the Field Regulatory Operations Office inspectors and Regulatory Enforcement Unit officers of FDA shall seize and/or confiscate all Cosmic Carabao Gin products available in the market. Please report these erring food retailers to eReport, the online reporting facility of the Food and Drug Administration, which can be accessed at www.fda.gov.ph/ereport or call 857-1900 local 8112 and 8115. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products. All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents: The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. In order to have an efficient and orderly releasing of FDA Authorizations at the Food and Drug Action Center (FDAC), the following guidelines shall be strictly implemented: A. Please note the following changes in schedule: Only the first one-hundred (100) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue. Medicamentos Oncológicos na Prática Clínica. The manufacturing facility of Juan Brewing, Inc. shall be inspected and investigated for any possibility of adulteration specifically the addition of methanol during processing. This section features important safety information on medicines which may impact public health and safety. On behalf of the ISoP Executive Committee and the Local Organizing Committee, it is our great pleasure to welcome you to the 19th Annual Meeting of the International Society of Pharmacovigilance (ISoP 2019), “New opportunities for new generations”, in Bogota, Colombia from the 26th to 29th October 2019. The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines. Angela Caro, Chair Local Organising Committee, Contact: Please note that photocopy of each required document is needed for every request. To report continuous unauthorized sale or distribution of drug products, kindly email us via [email protected], or through the online reporting facility, eREPORT, at www.fda.gov.ph/ereport. Sten Olsson, President ISoP Given that glutathione affects the production of melanin (the pigment that gives the human skin, hair and eyes their color) — there are theoretical concerns about the long term skin cancer risk.
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