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Vibha Sharma

Vibha Sharma is a senior reporter covering pharmaceutical and medtech regulatory developments across the globe. She joined Scrip Regulatory Affairs in September 2010 and has since then been at the center of deciding and writing news on important regulatory issues affecting the pharma and medtech sectors and explaining their implications for the industry.

Her fields of interest include the EU Pharmacovigilance legislation and the EU Paediatrics Regulation on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.

Before joining Informa, she was principal correspondent with India's national newspaper Hindustan Times, where she reported on health and medical issues, besides several other topics. She has also worked with two other Indian national dailies, The Indian Express and The Asian Age.

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Opioid Indications Under TGA Scrutiny As Australia Tackles Growing Misuse

The Australian drug regulator is reviewing the indications, pack sizes and information documents for consumers of potent opioid products to see how misuse and overdoses can be prevented.
Australia Drug Safety

New Head For EMA's Orphan Drugs Committee

A key priority for the new chair will involve reinforcing how the European Medicines Agency’s orphan drugs committee interacts and communicates with other scientific committees at the agency and other international partners.
Europe Rare Diseases

Health Canada Consults On Changes To List Of Recognized Medtech Standards

Canada has proposed 15 new additions and other changes to its list of recognized medtech standards. By demonstrating conformity with the recognized standards, device-makers can satisfy the safety and effectiveness requirements of the Canadian medical device regulations.

Canada Safety

EU Guide On Handling IMPs Draws Industry Concern

Pharmaceutical companies believe that some aspects of the draft EU guideline are potentially confusing or may be difficult to implement.
Europe Clinical Trials

Transparency, IP Issues Dominate Discussion On WHO's Roadmap To Improve Drug Access

Advocacy groups want the WHO's proposed roadmap on improving access to medicines to include stronger language on transparency of R&D costs, prices and revenues. The pharmaceutical industry, however, believes any forward-looking solution should rest upon strong IP protection.
International Intellectual Property

EMA Postpones Decision On Next Phase Of EudraVigilance To End Of 2019

The European Commission has agreed to extend the ongoing signal detection pilot involving the revamped EU pharmacovigilance database and has asked for a report on experience in the first year. 
Europe Drug Safety
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