The uncertainties looming over the Brexit have caused worries on the global economy and also the continuity of quality healthcare services. However, much less has been discussed on the implications of this momentous decision in the Asia Pacific, especially regulatory authorities which reference the health product decisions made in the EU and UK. Hear from two experts who are deeply involved on this matter, sharing on the potential effects of Brexit on access to health products, how this may influence activities in this region, and what can be done to better prepare our systems against the impact.
Scientific breakthroughs, growing amounts of healthcare data and globalization hold great promises for better health outcomes for patients in need.
Data analytics, real-world evidence, remote clinical monitoring, connected health records, electronic labeling and mobile health apps are among some of the trending topics that will shape the healthcare landscape in the coming years.
Alongside the advances in scientific understanding and health product development overall, paradigm shifts in regulatory processes and global convergence are important for greater synergy among all to bring forth timely innovation benefits to patients and consumers and patients that will improve health outcomes.
The International Council for Harmonisation (ICH) has recently announced the development of the new Quality guidelines (Q13 and Q14) relating to continuous manufacturing and analytical procedure development respectively. In addition to guiding the industry and regulatory agencies on the requirements of continuous manufacturing technologies used in the manufacture of pharmaceuticals, these also reflect the key intent to harmonise the scientific approaches of analytical procedure development, through understanding the underlying principles. This seminar provides a valuable opportunity to hear from Dr Moheb who is highly involved in developing these guidelines, as he draws also from his immense experience to share on the impact of the trending movement in the regulation of pharmaceuticals
In the effort to enable realisation of the Council for Harmonisation (ICH) Quality Vision established in 2003, which is to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science”, ICH have developed the following Quality Guidelines: ICH Q8/11, 9 and 10, and thereafter the draft ICH Q12 guideline that addresses the technical and regulatory considerations for pharmaceutical product lifecycle management. ICH Q8/11, 9 and 10 provide high-level direction with respect to the scope and definition of “Quality-by-Design”(QbD), following the concept that quality should be designed into a product. ICH Q12 provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. The shift towards conceptual framework guidelines has become increasingly important given the dynamic nature of the pharmaceutical industry, including complex global pharmaceutical supply chains, and more product diversity and innovation. The 2-day ICH workshop on ICH Q8/11, 9, 10 and 12 guidelines strives to foster better understanding of this new quality paradigm and to address the potential challenges in their implementation in the ASEAN and greater Asia-Pacific region.
Pharmacovigilance is one of the key regulatory function that monitors the safe effective use of pharmaceuticals in the real-world healthcare setting. It has progressively included risk management planning, which encompasses appropriate drug use, signal detection and other risk minimisation activities, for better product lifecycle management. Within this module, the principles, frameworks and processes for pharmacovigilance will be introduced. Various platforms and partnerships among regulatory stakeholders for ensuring adequate and quality pharmacovigilance data will be also covered.
The effective regulation of pharmaceuticals for safety and efficacy depends on the availability, understanding and appropriate implementation of relevant guidelines and the processes designed to ensure quality in decision-making. The requirements are frequently different from traditional clinical trials and specific to regulatory affairs. This four-credit module provides the understanding for the unique requirements of clinical trials and clinical data meant to support regulatory evaluation and approvals.
REGISTRATION FOR AY2019/2020 SEM 1 IS NOT OPEN.
Regulation of pharmaceuticals is controlled by standards, guidelines and legal frameworks. The interactions among these and the stakeholders – industry, regulatory authorities, healthcare professionals and patients – are required for effective governance for safe, quality and efficacious medicines and timely access for patients. This fundamental module provides an understanding of the contribution of the various stakeholders, functions and guidelines that shape the regulatory environment and impact the healthcare management scene. The concept of product lifecycle will be also be explored among other contemporary regulatory approaches.
REGISTRATION FOR AY2019/2020 SEM 1 IS NOT OPEN.
The assurance of safe and quality medicines in the market depends on a range of vital activities after the approval of a medicine by the authorities. This includes the continual monitoring offered by inspections and audits of facilities and testing of product quality. In this globalized environment, there is also an increasing need to leverage on networks to effectively detect lapses in product quality and services in a timely manner. Key activities and roles essential for effective post-market control, will be introduced, including managing failures of conformance and compliance. Topics covered will include collaborations and networks for optimising post-market communications, and handling of substandard and falsified pharmaceuticals.