VOINews, Jakarta - The Food and Drug Supervisory Agency (BPOM) is seeking to increase its pharmacovigilance (drug safety monitoring) capacity via risk management plans (RMP).
"BPOM carried out innovation by revitalizing the effective pharmacovigilance system through the BPOM Regulation Number 15 of 2022 concerning the Implementation of Pharmacovigilance," the head of the agency, Penny K. Lukito, informed in a statement released on Tuesday.
In accordance with the regulation, one of the pharmacovigilance implementation stages is regulating the RMPs of the pharmaceutical industry as part of pre-market supervision, she said.
Lukito explained that the RMP is a document that is designed to identify, determine characteristics, and prevent, or minimize the risks of drugs before they are distributed.
"The pharmaceutical industry has an obligation to prepare RMP documents that cover the drug development process to product distribution. This document is an inseparable part of the product registration document," she said.
According to her, the implementation of the obligation to prepare RMP documents has been carried out in stages. Based on data for the January–August 2023 period, RMP document submissions have only reached 30 percent of all new drug registration applications received by the agency.
Therefore, the BPOM is holding a workshop related to RMP document preparation from September 19–21, 2023, to assist the pharmaceutical industry in preparing RMP documents, strengthen efforts to implement RMPs, including Environmental Risk Assessment (ERA) at the drug registration stage, and strengthen BPOM's evaluators in evaluating RMP documents.
"In general, the RMP document preparation aims to identify early product risks and sectors that require further evaluation," Lukito said.
In the future, RMPs will also be needed to plan new research to identify the risks of drugs to prevent negative impacts on patients and the environment, she added.
"RMP documents must contain ERA. We need to identify the risks of drugs from the start and plan action to avoid it," she disclosed. (Antaranews)
VOInews.id, Jakarta: Reog dance from Ponorogo, East Java performed as the closing at the Indonesian Cultural Night 2023 event, Sunday (17/9). This performance took place in front of around 1,200 spectators who filled the Pic-Ganesha Theater, Siam Square One, Bangkok, Thailand. With a duration of approximately 12 minutes, the Reog Dance performed by the Brawijaya University (UB) dance team tells a story entitled Hastabrata.
"Taking the theme Hastabrata, the Reog Ponorogo dance this time tells the concept of policy and leadership wisdom in Javanese culture, especially East Java," wrote a statement from the Indonesian Embassy in Bangkok received by Indonesia Window here on Tuesday (19/9).
In this performance, the movements of Warok dancers who are thick with their courage are combined with the agility and cheerfulness of Jathil dancers. In addition, there is the presence of Bujang Ganong, who is accompanied by Kelana Sewandana to fight repeatedly against Dadak Merak. The fight that Bujang Ganong and Kelana Sewandana finally win brings out the moral message that good always wins against bad.
The Reog performance at the Indonesian cultural night was accompanied by musical instruments brought from Indonesia. This is supported by the lighting by the sparkling spotlights and stage lights, which support the atmosphere of each scene. Puffs of smoke were also featured in the fight scene between Bujang Ganong and Kelana Sewandana against Dadak Merak.
The Indonesian Embassy in Bangkok, the organizer of this event, said the dancers performed stunningly. The audience, consisting of various groups such as the diplomatic corps and Thai students, admired the performance.
"The audience's admiration was seen from every corner of the performance theater room, and with a very lively applause at the end of the Reog Ponorogo performance," the statement continued.
UB Secretary, Dr. Tri Wahyu Nugroho, said he wanted the Thai people to get to know the culture of East Java through this performance. He said the Reog Dance will be preserved for the next generations of young people in Indonesia, especially in East Java.
Education and Culture Attaché at the Indonesian Embassy in Bangkok, Achmad Wicaksono, said the team had won several national competitions. This includes the last competition, which was held in July 2023. He hopes that cultural exchanges between the two countries, such as Reog Poronogo which has never been performed in Thailand, will increase.
Indonesian Cultural Night 2023 is part of the promotion of Trade, Tourism, Investment, and Cultural Forum organized by the Indonesian Embassy in Bangkok. This activity, which is claimed to be organized in an integrated and sustainable manner, is an effort to strengthen cooperation in various fields with Thailand. (VOI/Rama)
VOInews, Jakarta: Indonesian Foreign Minister Retno Marsudi has expressed the commitment of the Association of Southeast Asian Nations (ASEAN) to narrow the development gap and strengthen the implementation of the Sustainable Development Goals (SDGs) locally.
"Including through empowering youth, women, the elderly, MSMEs, and migrant workers," she said while attending the Sustainable Development Goals (SDGs) Summit at the UN Headquarters in New York as quoted from an official statement of the Indonesian Ministry of Foreign Affairs received by Indonesia Window here on Tuesday (19/9/2023).
In addition, the Indonesian Foreign Minister said, ASEAN is also committed to becoming a resilient community, by increasing investment to sustainable energy security.
"By increasing investment in human resource development, health infrastructure, digital transformation, strong supply chains, and sustainable energy security," she continued.
Not only that, ASEAN also continues to strengthen multilateralism and respect for the UN charter. "That way, the implementation of the Sustainable Development Goals (SDGs) can get back on track," she added.
Indonesian Foreign Minister Retno Marsudi also encouraged countries to provide equal opportunities for developing countries to grow and make development leaps.
"There is no other choice, the world must encourage the creation of a conducive environment for developing countries to grow and make leaps of development. Trade discrimination must stop. Developing countries must be given the opportunity to downstream industries," he said.
The SDGs Summit is an official UN meeting held every four years at the Head of State/Government level to review progress and challenges in the implementation of the 2030 Agenda for Sustainable Development. (VOI/Rama)
U.S. Secretary of State Antony Blinken met with Chinese Vice President Han Zheng on Monday on the sidelines of the United Nations General Assembly, the latest in a series of meetings aimed at reducing tensions between the world's two largest economies.
In a statement after the meeting, the U.S. State Department said the talks involved "a candid and constructive discussion." The two agreed to maintain open lines of communication and discussed Russia's invasion of Ukraine, North Korea and the Taiwan Strait, the department added.
The talks between Blinken and Han could help set the stage for a meeting between U.S. President Joe Biden and Chinese President Xi Jinping later this year.
They followed 12 hours of meetings last weekend between White House national security adviser Jake Sullivan and Chinese Foreign Minister Wang Yi in Malta.
"The world expects us to responsibly manage our relationship," Blinken said in brief remarks at the beginning of his meeting with Han. "The United States is committed to doing just that," he added.
"From the perspective of the United States, face-to-face diplomacy is the best way to deal with areas where we disagree, and also the best way to explore areas of cooperation between us," Blinken said.
Blinken, U.S. Commerce Secretary Gina Raimondo, Treasury Secretary Janet Yellen and Biden climate envoy John Kerry have traveled to China this year to thaw relations and ensure continued communication between the two countries amid tensions that flared after the U.S. military shot down a Chinese surveillance balloon that traveled over the United States.
Biden this month expressed disappointment that Xi had skipped a summit of Group of 20 leaders in India, but said he would "get to see him."
The next likely opportunity for Biden to hold talks with Xi is an Asia-Pacific Economic Cooperation summit in San Francisco in November, where U.S. aides for months have hoped to stage such a meeting.
Neither Blinken nor Han in their remarks explicitly mentioned whether such a meeting would materialize.
"Currently, China-U.S. relations face many difficulties and challenges," Han told Blinken, noting that China hoped the U.S. would make efforts to implement the consensus reached by the two countries' leaders and promote the stable development of relations.
"The world needs stable and healthy China-U.S. relations," Han said.
The U.S. and China are at odds over issues ranging from Taiwan to trade, fentanyl and human rights. Critics of the Biden administration have questioned its strategy of engaging China, warning that a failure to push back on provocations, including the recent China-linked hacking of senior U.S. officials' email, could embolden Beijing.
Federal Bureau of Investigation Director Chris Wray told a conference on Monday that China has a cyberespionage program so vast that it is bigger than all of its major competitors combined.
Ryan Hass, a China expert at the Brookings Institution, said the pace of high-level exchanges between Washington and Beijing suggested that efforts were "purposeful" and not just part of relationship management.
"I expect both sides are working to set the stage for a productive meeting between both leaders in November," Hass said. (Reuters)